PB 718 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Covance Clinical Research Unit Inc., Daytona Beach, FL
Healthy Subjects (HS)
PB 718 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether there are differences in the effects of single and multiple doses of LSD.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

This trial is evaluating whether PB 718 will improve 1 primary outcome and 1 secondary outcome in patients with Healthy Subjects (HS). Measurement will happen over the course of From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks..

Week 11
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Pharmacokinetic (PK) profile

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

11 Treatment Groups

Group A4
1 of 11
Group A3
1 of 11
Group A2
1 of 11
Group B3
1 of 11
Group A1
1 of 11
Group B4
1 of 11
Group A6
1 of 11
Group A5
1 of 11
Group B1
1 of 11
Group B2
1 of 11
Placebo
1 of 11
Experimental Treatment
Non-Treatment Group

This trial requires 80 total participants across 11 different treatment groups

This trial involves 11 different treatments. PB 718 is the primary treatment being studied. Participants will be divided into 10 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Group A4PB-718 vs placebo
Group A3PB-718 vs placebo
Group A2PB-718 vs placebo
Group B3PB-718 vs placebo
Group A1PB-718 vs placebo
Group B4PB-718 vs placebo
Group A6PB-718 vs placebo
Group A5PB-718 vs placebo
Group B1PB-718 vs placebo
Group B2PB-718 vs placebo
PlaceboThe reference product (placebo) will be identical to PB-718 (PB-119/PB-722) and will be administered subcutaneously in the abdomen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2810

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from group a1 until group b4. the study duration for each subject in part a will be approximately 8 weeks. the study duration for each subject in part b will be approximately 11 weeks.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from group a1 until group b4. the study duration for each subject in part a will be approximately 8 weeks. the study duration for each subject in part b will be approximately 11 weeks. for reporting.

Closest Location

Covance Clinical Research Unit Inc. - Daytona Beach, FL

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject is in good health, as determined by a medical history, physical examination, 12-lead ECG, and vital signs measurements show original
The subject can understand the requirements of the study and is willing to sign an ICF and follow the study restrictions. show original
People between the ages of 18 and 55 who are of any race. show original
Part A: Male subjects will weigh at least 50 kg, and female subjects will weigh at least 45 kg show original

Patient Q&A Section

What causes healthy subjects (hs)?

"The majority of the hs in this study had not had symptoms prior to study enrollment, indicating some degree of subclinical disease in this sample. The most common reason cited for enrollment in these studies was for participation in clinical trials. However, the overall health status and health-related characteristics of the hs did not differ from those of a large, nationally representative database of US adults in terms of most medical conditions, medical utilization, prescription drugs, or socioeconomic status." - Anonymous Online Contributor

Unverified Answer

What are the signs of healthy subjects (hs)?

"Since hs does not suffer any damage from chemotherapy and radiation therapy, it can only be recommended to perform health evaluations if they are at risk of getting SCC." - Anonymous Online Contributor

Unverified Answer

What are common treatments for healthy subjects (hs)?

"There are many treatments used to treat common conditions. While some treatments may have some benefit, their use varies greatly across studies. Results from a recent paper provides several guidelines for clinicians to use in their practice. By considering the frequency and effectiveness of treatments for individual disorders, clinicians can provide a more consistent care option to their patients. There is a necessity for more research to be conducted that focuses on the effects of treatment on patients and their quality of life." - Anonymous Online Contributor

Unverified Answer

What is healthy subjects (hs)?

"The HSR is useful for identifying subjects with asymptomatic diseases or with subclinical diseases, but it should be used only cautiously when evaluating participants with symptomatic diseases." - Anonymous Online Contributor

Unverified Answer

How many people get healthy subjects (hs) a year in the United States?

"Despite an [increasing] number of studies evaluating the generalizability of nonrandomized trials of medical interventions, hs are still frequently used in the United States. The hs issue needs to be tackled by the [research and publishing] community to ensure [that these trials] are scientifically based and justified." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets healthy subjects (hs)?

"At least one-third of HSA-SES visits in 2014 were for patients under 55 years, the highest proportion we had seen in our institution over the last 12 years." - Anonymous Online Contributor

Unverified Answer

What is pb 718?

"If you have had a hysterectomy and had endometriosis, the UroVysion Pb 718 may help show if the [tubal ligation] in your past is responsible for menstrual irregularities. The UroVysion Pb 718 is NOT available for [menstrual cycle disorders without endometrioses] (without hysterectomy)." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for healthy subjects (hs)?

"As the number of clinical trials is increasing, clinicaltrials.gov now offers an exhaustive list of clinical trials, including those specifically designed for healthy subjects. We urge patients and their families alike to consider participation in clinical trials before starting a new treatment regimen. ClinicalTrials.gov (http://wwwnCT01052837-1) also offers clinical trials information, including patient education and resources, as well as links to other lupus and inflammatory disorders clinical trials." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pb 718 for therapeutic use?

"While the development of bispecific antibodies is a major advance, the development of chimeric antibodies is also of interest. While an antibody to a cancer specific antigen is preferable, an antibody that binds to a T cell costimulatory molecule is feasible. In the future, the search for a monospecific antibody to a single CD3 antigen should broaden our repertoire of T cell costimulatory molecules, and further our knowledge of tumor and T cells." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating healthy subjects (hs)?

"Results from a recent paper of these studies indicate that a high dose of oral vitamin D3 with or without vitamin D3 with UVB phototherapy should increase insulin sensitivity. Higher dose of vitamin D3 may decrease insulin resistance in hs. We expect these high‐quality trials would be included in any clinical practice guidelines or guidelines on hs in the future." - Anonymous Online Contributor

Unverified Answer

Is pb 718 safe for people?

"pb 718 was well tolerated and was effective in reducing serum ferritin in patients with iron overload. A randomized trial of pb 718 in patients with chronic hepatitis B is therefore desirable." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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