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NCT06236009 · ClinicalTrials.gov registry record · Phase 1
A First-In-Human Study of TAK-004 in Healthy Adults
A Phase 1 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
- 1
- Study location
NCT06236009 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 121 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06236009, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is the first study with TAK-004 conducted in human beings. Participants will receive either TAK-004 or placebo. The main aim of this study is to learn how safe TAK-004 is in healthy adults and how well participants tolerate one or more doses of TAK-004. Other aims are to learn about the effects of TAK-004 on the heart rate and blood pressure and if TAK-004 creates an immune response (immunogenicity). Another aim is to learn how the body of healthy adults affects TAK-004 (pharmacokinetics). Participants will receive TAK-004 or placebo via injection just under the skin (subcutaneous injection or SC injection). Depending on the groups participants are assigned to, they will either receive just one dose of TAK-004 or placebo or multiple doses of TAK-004 or placebo while they are in the study. Blood and urine samples will be taken during the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-004
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2025-10-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06236009
The ClinicalTrials.gov registry entry for NCT06236009 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (75% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06236009 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT06236009 about?
NCT06236009 is a clinical study titled "A First-In-Human Study of TAK-004 in Healthy Adults". This study is the first study with TAK-004 conducted in human beings. Participants will receive either TAK-004 or placebo. The main aim of this study is to learn how safe TAK-004 is in healthy adults and how well participants tolerate one or more doses of TAK-004. Other aims are to learn about the e...
What is the current status of trial NCT06236009?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2024-11-01. Estimated completion is 2025-10-17.
What conditions does trial NCT06236009 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT06236009?
The interventions under investigation include: Placebo (DRUG), TAK-004 (DRUG).
Who is sponsoring clinical trial NCT06236009?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06236009 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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