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Part 3: TAK-105-a for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to month 18
Awards & highlights

Study Summary

This trial is testing a new drug, TAK-105, to see if it is effective in treating nausea and vomiting. The study will test different doses of the drug to see what is safe and what works best.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With At Least one Adverse Event
Secondary outcome measures
Number of Participants Based on Antidrug Antibody (ADA) Levels in Serum
Parts 1, 2, 5a, 5b, and 6, CL/F: Apparent Clearance After Extravascular Administration for TAK-105
Parts 1, 2, 5a, 5b, and 6, Cmax: Maximum Observed Plasma Concentration for TAK-105
+12 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Parts 5a and 5b: TAK-105-aExperimental Treatment2 Interventions
TAK-105-a dose TBD or TAK-105-a placebo-matching solution, subcutaneously, once on Day 1 for the SRD Cohorts (Cohorts 28 to 30), during Part 5a of the study and TAK-105-a dose TBD or TAK-105-a matching-placebo, subcutaneously, once weekly for 4 weeks for the optional MRD Cohorts (Cohorts 31 and 32), during Part 5b of the study. Dose of the SRD and optional MRD Cohorts (28 to 32) will be determined during the dose escalation meeting based on emerging safety, tolerability, and available PK data during the study. The MRD Cohorts in Part 5b will be optional, depending on the PK, safety data observed in Part 2 MRD.
Group II: Part 6: TAK-105-bExperimental Treatment2 Interventions
TAK-105-b dose TBD or TAK-105-b placebo-matching solution, subcutaneously, once on Day 1. Dose of the SRD Cohorts (33 and 34) will be determined during the dose escalation meeting based on emerging safety, tolerability, and available PK data from Part 1 (SRD).
Group III: Part 4: TAK-105-aExperimental Treatment2 Interventions
TAK-105-a dose TBD or placebo-matching solution, subcutaneously, once a week for 2 weeks, followed by a period of withholding drug and then redosing with a third dose. Part 4 (Cohorts 24 to 27) will provide an exploratory evaluation to assess the safety and CV tolerability profile of redosing with TAK 105.
Group IV: Part 3: TAK-105-aExperimental Treatment2 Interventions
TAK-105-a dose TBD or placebo-matching solution, subcutaneously, once weekly for 2-4 weeks. Dose for the first 2 Cohorts (Cohorts 18-19) of Part 3 will be based on emerging safety, tolerability, and available PK data from Part 1 single rising dose (SRD) and Part 2 (MRD) as determined in the dose escalation meeting. The data from Cohorts 18-19 will further determine additional enrollment of Cohorts 20, 21, 22 and 23. Part 3 will evaluate whether dose titration result in different tolerability in relation with CV observations.
Group V: Part 2: TAK-105-aExperimental Treatment2 Interventions
TAK-105-a dose to be decided (TBD) or TAK-105-a matching-placebo, subcutaneously, once weekly for 4 weeks. Dose of multiple rising dose (MRD) Cohorts (Cohorts 13-17) of Part 2 will be determined based on emerging safety, immunogenicity, tolerability, and PK data from Part 1 (SRD) determined in the dose escalation meeting.
Group VI: Part 1: TAK-105-aExperimental Treatment2 Interventions
TAK-105-a at starting dose of 30 microgram (mcg) or placebo-matching solution, subcutaneously, once on Day 1. Staggered dosing will be done in the first cohort of Part 1 (Cohort 1). Staggered dosing in subsequent Cohorts (Cohorts 2-12) may be used. After the pre-specified first dose, subsequent doses will be determined in the dose escalation meeting based on emerging safety, tolerability, and PK data from the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-105-b Placebo
2021
Completed Phase 1
~80
TAK-105-a
2021
Completed Phase 1
~80
TAK-105-a Placebo
2021
Completed Phase 1
~80
TAK-105-b
2021
Completed Phase 1
~80

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,182 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,208 Previous Clinical Trials
489,615 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to participate in this trial?

"The trial is in need of 216 volunteers aged 18 to 55 with a healthy physique (hs). Additionally, they must meet the following conditions: BMI between 18.0 and 30.0 kg/m^2; non-smoker for 3+ months prior and through discharge; upon investigation - no evidence of psychiatric, hepatic, renal, pulmonary or cardiovascular diseases based on clinical evaluations including laboratory safety tests, medical history etc."

Answered by AI

Is there currently an open call for participants in the experiment?

"This research effort, which was originally published on July 26th 2021 and recently modified on the 13th of July 2022 is no longer accepting volunteers. Fortunately there are 840 other clinical trials actively recruiting individuals to participate."

Answered by AI

Is TAK-105 a danger to human health?

"Limited clinical data is available for TAK-105's safety and efficacy, so it was assigned a score of 1 on our internal scale."

Answered by AI

Are those below the age of 55 capable of enrolling in this research?

"This clinical trial's criteria for enrollment limits possible participants to those between 18 and 55 years of age. For patients younger than 18 or older than 65, there are fifty studies and three hundred seventy-two trials respectively."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
18 - 65
What site did they apply to?
PPD Development, LP
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. PPD Development, LP: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-105 in Healthy Adults
2021. "A Study of TAK-105 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04964258.
~22 spots leftby Apr 2025
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