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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
1,208 Previous Clinical Trials
4,187,850 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,221 Previous Clinical Trials
499,907 Total Patients Enrolled
~21 spots leftby Jun 2025
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