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Part 1: TAK-105 Dose 1 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 part 1: day 1 pre-dose and at multiple timepoints (up to day 60) post-dose; part 2: day 1 pre-dose and at multiple timepoints (up to day 6) post-dose; part 2: day 22 pre-dose and at multiple timepoints (up to day 82) post-dose

Summary

This trial is testing a new drug called TAK-105 to see if it can safely treat nausea and vomiting. Healthy adults are participating to help researchers find out if the drug has any side effects and what the safe dosage levels are.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: day 1 pre-dose and at multiple timepoints (up to day 60) post-dose; part 2: day 1 pre-dose and at multiple timepoints (up to day 6) post-dose; part 2: day 22 pre-dose and at multiple timepoints (up to day 82) post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: day 1 pre-dose and at multiple timepoints (up to day 60) post-dose; part 2: day 1 pre-dose and at multiple timepoints (up to day 6) post-dose; part 2: day 22 pre-dose and at multiple timepoints (up to day 82) post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs)
Secondary study objectives
Number of Participants Based on Antidrug Antibody (ADA) Status
Other study objectives
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-105
Part 2, AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over Dosing Interval for TAK-105
Part 2, Ctrough: Observed Plasma Concentration at the End of a Dosing Interval at Steady State for TAK-105
+11 more

Side effects data

From 2023 Phase 1 trial • 80 Patients • NCT04964258
42%
Tachycardia
33%
Medical device site dermatitis
17%
Dizziness postural
17%
Constipation
17%
Headache
17%
Hypoglycaemia
8%
Medical device site reaction
8%
Cough
8%
Sinus arrest
8%
Medical device site erythema
8%
Extrasystoles
8%
Palpitations
8%
Fatigue
8%
Ventricular extrasystoles
8%
Ventricular tachycardia
8%
Chromaturia
8%
Medical device site papule
8%
Medical device site pruritus
8%
Muscle twitching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: TAK-105 Dose 1A
Part 1: Placebo
Part 1: TAK-105 Dose 6
Part 1: TAK-105 Dose 4
Part 1: TAK-105 Dose 1
Part 1: TAK-105 Dose 5
Part 1: TAK-105 Dose 7
Part 1: TAK-105 Dose 2
Part 1: TAK-105 Dose 3
Part 2: Placebo
Part 2: TAK-105 Dose 2A

Trial Design

11Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: TAK-105 Dose 2AExperimental Treatment1 Intervention
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
Group II: Part 2: TAK-105 Dose 1AExperimental Treatment1 Intervention
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for up to 4 weeks.
Group III: Part 1: TAK-105 Dose 7Experimental Treatment1 Intervention
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
Group IV: Part 1: TAK-105 Dose 6Experimental Treatment1 Intervention
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
Group V: Part 1: TAK-105 Dose 5Experimental Treatment1 Intervention
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
Group VI: Part 1: TAK-105 Dose 4Experimental Treatment1 Intervention
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
Group VII: Part 1: TAK-105 Dose 3Experimental Treatment1 Intervention
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
Group VIII: Part 1: TAK-105 Dose 2Experimental Treatment1 Intervention
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
Group IX: Part 1: TAK-105 Dose 1Experimental Treatment1 Intervention
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
Group X: Part 1: PlaceboPlacebo Group1 Intervention
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
Group XI: Part 2: PlaceboPlacebo Group1 Intervention
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-105-a
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
1,235 Previous Clinical Trials
4,147,825 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,271 Previous Clinical Trials
503,845 Total Patients Enrolled
~19 spots leftby Nov 2025
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