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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: Completed Phase 1 study of Healthy Volunteers, sponsored by Takeda.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study investigational product (IP), whether or not the occurrence is considered related to the study IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study IP. An untoward finding generally may necessitate therapeutic intervention, require an
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 |
What the finished NCT06236009 record still lists
NCT06236009 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06236009's enrollment target sits among peer trials
121 70th of 283 higher than 214 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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