The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in participants with AD, non-Japanese, and Japanese healthy participants who are of first-generation Japanese origin. The study will also investigate how much LY3372993 gets into the bloodstream and will test the effects of LY3372993. The study will be conducted in two parts. The part A includes participants with AD and part B includes healthy participants. Participation could last up to about 61 weeks and may include up to 31 visits to the study center.

A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants

LY3372993 for Alzheimer's Disease

This study is evaluating whether a drug may help treat Alzheimer's disease.

I have had serious dizziness or fainting episodes in the last 3 years.

(Part B) You have any important heart or brain scan irregularities.

I haven't taken any biologic drugs like monoclonal antibodies in the last 3 months or 5 half-lives, whichever is longer.

You have a serious or unstable illness that could affect the study or the treatment, or could shorten your life expectancy.

You have high or abnormal blood pressure or pulse rate, or have a history of high blood pressure.

If you want to take part in the study, you and your family must have Japanese heritage, and all your grandparents must have been born in Japan.

My family has a history of Alzheimer's disease before age 65.

I have uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or a known immune deficiency.

Your lab test results are normal or have minor deviations that are not a big concern for the doctor.

You cannot have a positron emission tomography (PET) scan for medical reasons.

I have used or plan to use medication, including herbal ones, within 14 days before dosing.

You have a Mini-Mental State Examination score of 16 or higher.

You have a history of serious mental health problems.

I have been experiencing worsening memory issues for over 6 months and have been diagnosed with mild cognitive impairment or Alzheimer's dementia.

LY3372993

Placebo

WCCT Global Clinical Trials 2022

The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in healthy Japanese and Caucasian participants. The study will also investigate how the body processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4 weeks for each participant. Screening may occur within 28 days prior to first dose of study drug.

A Study of LY3337641 in Japanese and Caucasian Healthy Participants

A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3337641 in Japanese and Caucasian Healthy Subjects

Chief Medical Officer

All randomized participants who received at least one dose of study drug.

The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.

A Study of Mirikizumab (LY3074828) in Healthy Participants

A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Japanese and Caucasian Healthy Subjects

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

OCT Agreement and Crossed Precision Study

Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry

To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.

Study of REGN3500 and Dupilumab in Patients With Asthma

A Randomized, Placebo-controlled, Parallel Panel Study to Assess the Effects of REGN3500, Dupilumab, and Combination of REGN3500 Plus Dupilumab on Markers of Inflammation After Bronchial Allergen Challenge in Patients With Allergic Asthma

Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.

Compare Bioavailability of RO7239361 After Subcutaneous Injection

An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RO7239361 in Healthy Participants

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

This study will consist of the following:

Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.

A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years With Seasonal Allergic Rhinitis

Respiratory Medical Director

Safety analysis set consisted of all participants who received at least 1 dose of lanadelumab.

The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched non-Hispanic healthy adult Caucasian subjects.

Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of a Single Dose of Lanadelumab Administered Subcutaneously in Healthy Adult Japanese Subjects and Matched Healthy Adult Caucasian Subjects

Study Director

This study will evaluate the safety, tolerability and pharmacokinetics of USB005 (aclerastide) Ophthalmic Solution.

Study of the Safety of USB005 in Healthy Volunteers

This is a Phase 1, single-center, randomized, double-masked, placebo-controlled, multiple ascending dose study in healthy volunteers. Thirty-two male and female volunteer subjects, between the ages of 18 and 64 years of age, will be enrolled. Subjects will be enrolled in four dose-escalating cohorts of eight subjects and randomized to USB005 or placebo in a ratio of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration. The four cohorts will be identified as: Cohort 1(0.03% USB005 or placebo), Cohort 2 (0.1% USB005 or placebo), Cohort 3 (0.3% USB005 or placebo), and Cohort 4 (0.45% USB005 or placebo). Volunteers in the four cohorts will self-administer a single drop of USB005 or placebo into the study eye, three times a day for 28 days. The study eye in which the drug is applied to will be determined based on screening assessments. Subjects will be followed for 8 days after the last USB005 or placebo administration.

The safety and tolerability of USB005 will be demonstrated by local toxicity, adverse events, laboratory assessments, vital signs, and a comprehensive eye exam. Plasma samples will be taken at various time points throughout the study to characterize the pharmacokinetics of USB005. Dropouts will be replaced after consultation with the Sponsor.

Evaluation of USB005 in a Phase 1 Normal, Healthy Volunteer Ocular Safety and PK Study

This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males.

Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.

A Single Ascending Dose Study of PCO371 in Healthy Volunteers

A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers

The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects

A Phase I, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects in Healthy Male and Female Japanese Subjects After Single and Multiple Doses (Bid) of AZD1722

The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants

A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose administration.

A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants

A Double-blind, Placebo-controlled, Randomized, Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Subjects

This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety, pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection and nalbuphine injection.

A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.

This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers.

Each subject in a cohort will be evaluated for study eligibility during the screening period, which is within 28 days prior to receiving the study drug (Day 1). Eligible subjects will be admitted into the study site on Day -1 and will be required to stay in clinical site for 5 (Cohort 1) or 2 nights (Cohort 2) for study procedures in each cohort. Eligible subjects will undergo additional eligibility assessments on Day -1 and those reconfirmed eligible will intramuscularly receive NALDEBAIN ER Injection (Cohort 1) or nalbuphine (Cohort 2) on Day 1.

The blood sampling timepoints for Cohort 1 will be at predose, 6, 12, 24, 48, 56, 64, 72, 80, 88, and 96 hours after dosing. Subjects will be discharged after the 96-hour blood sample and return to the clinical site for the sample collection at 120, 168, 216, 288 and 360 hours post dosing. The blood sampling timepoints for Cohort 2 will be predose, 5, 15, and 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose.

Subjects will return for a follow-up visit to complete safety evaluations for approximately 15 days after study drug administration in cohort 1; and 1 days after study drug administration in Cohort 2.

This study is evaluating whether a new form of a medication may be more effective than the current form.

This is a randomized, double-blind, within-subject placebo controlled study to evaluate the safety and efficacy of various doses of STP705 administered as intradermal Injection in subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose, the pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers common to the scar formation pathway.

A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar

This single-center, randomized, double-blind, within-subject placebo controlled study is designed to evaluate the safety and efficacy of various doses of STP705 administered as intradermal injection in subjects with linear hypertrophic scar.

Twenty four subjects will be divided equally among 3 cohorts (20, 30 and 40 μg/cm2/day dose level) of 8 subjects each. Each subject will receive both active (STP705) and control (Placebo) treatment twice a week for a total of 4 weeks. The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar.

Subjects will be confined to clinic or research unit for 24 hours post-dosing after the first treatment administration for the serial PK assay and the blood sample will be collected at the following post-dosing times: 30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs, 5hrs, 6 hrs, 8 hrs, 12 hrs, 16 hrs, 24 hrs, 32 hrs and 36 hrs. Post-dosing ECG will be performed 6 hours (±1 hr) after the first study drug administration and vital signs will be monitored every 2h till 12h post-administration. Adverse events and medications will be monitored throughout the study.

A Randomized, Double-Blind, Within-Subject Placebo Controlled Study to Evaluate the Safety and Efficacy of Various Doses of STP705 Administered as Intradermal Injection in Subjects With Hypertrophic Scar.

All 101 randomized participants took at least 1 dose of double-blind study treatment, which also comprises the Safety Population of 101 participants

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.

This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.

This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation

Therapeutic Area Head

AEs, both serious and non-serious, occurring between signing informed consent and through the Termination Visit will be recorded on the eCRFs. All AEs/SAEs should be monitored until they are resolved, are not expected to improve further, or are determined to be due to a stable or chronic condition or intercurrent illness. Any AE/SAE that occurs with an onset date > 30 days after study completion and that the Investigator considers to be related to study medication, must be reported to Portola.

The safety population will consist of all subjects randomized and treated with at least one dose of study medication (andexanet, andexanet placebo, or betrixaban). All safety analyses will be performed by actual treatment received.

This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of betrixaban.

A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing

A Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered Andexanet After Dosing to Steady-State With Oral Betrixaban in Healthy Subjects

Head of Clinical Development

The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.

Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion

Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid:

SUN-131 1.5% TDS (n=30)
Placebo TDS (n=30)

At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself.

All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present.

There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS.

Data review and safety assessments will be conducted by the medical monitor periodically throughout the trial and at the conclusion of the study.

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN 131 Transdermal System (TDS) as Compared to Placebo TDS in Adult Patients With a Chalazion

The primary objective of the study is to compare the safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.

Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Evinacumab in Healthy Japanese and Caucasian Subjects

This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.

Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ME1100 Inhalation Solution (Arbekacin Inhalation Solution) Administered to Healthy Volunteers

AEs were categorized by solicited AEs, unsolicited AEs (including both AESIs and NOCIs), and SAEs, where the frequencies and durations of each were summarized by cohort, severity, and relatedness to study treatment.

To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

This study is evaluating whether a vaccine may help prevent a disease.

A Phase 1b, Open-label, Boost-optimization Study of an Adenoviral- Vector Based Oral Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered Orally to Healthy Adult Volunteers

Vice President Regulatory

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety analysis set included all participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received.

Randomized Set included all participants who were randomized into the study, regardless of whether they received any dose of the study drug.

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.

The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

Vedolizumab 300 mg IV
Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

Medical Director

Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and non-Japanese Healthy Subjects

Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects

An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101 (Calcifediol) Extended-release Capsules in Japanese and non-Japanese Healthy Subjects

An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101 (Calcifediol) Extended-release Capsules in Japanese and Non-Japanese Healthy Subjects

The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body

A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects

A Randomized, Parallel, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 in Healthy Japanese and Non-Japanese Subjects

Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.

Dietary Supplement With and Without a Probiotic

The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastrointestinal health.

The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-75.

This study is evaluating whether a combination of a probiotic and a complex carbohydrate may help improve the gut microbiome.

Dietary Study of a Complex Oligosaccharide With and Without a Probiotic in Healthy Volunteers

The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.

A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body

A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects

Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection of florbetapir or flortaucipir. AEs occurring after study drug administration, but outside that window were not recorded in the database, unless considered attributable to study drug injection. MRI/Amyloid extension cohort n=4 represents only those subjects receiving florbetapir PET scans.

Baseline demographics analysis includes subjects receiving a florbetapir or a flortaucipir PET scan in the study.

This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.

Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects

An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects

This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT).

All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.

Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects

This study is a Randomized, Double Blind, Single-Dose, Two-Period Crossover Comparative Pharmacology Study

This is double blind study so participat healthy subjects and investigators both would be blinded

The current study design was prepared to assess and compare the PK, PD, safety, tolerability of the Adello biosimilar candidate, TPI-120 and the US-licensed reference product, Neulasta® after administering a single subcutaneous 2 mg dose in healthy adult subjects in a crossover design. The primary PK parameters are AUC0-t, AUC0-inf, and Cmax, and the primary PD parameters are baseline-corrected AUEC0-t and Emax for ANC.

This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT).

All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.

Later on management will decide whether to share the data or not

A Randomized, Double Blind, Single-Dose, Two-Period Crossover Comparative Pharmacology Study Comparing TPI-120 and Neulasta® Administered Through Subcutaneous Route in Healthy Adult Subjects

principal investigator

This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's.

A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051

This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's. Secondary Objectives: 1) To assess the pharmacokinetic (PK) profiles of REGN3048 and REGN3051 following co-administration of single IV doses (1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's); 2) To assess the immunogenicity of REGN3048 and REGN3051 following co-administration of single IV doses (1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's)

A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 vs. Placebo in Healthy Adults

This is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with Active Crohn's disease (CD) or Ulcerative Colitis (UC).

A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

This study is evaluating whether a medication which blocks certain immune cells may have an effect on the metabolism of other medications.

A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.

WCCT Global Clinical Trials 2022

Trials at this site

LY3372993 for Alzheimer's Disease

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