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NCT07229911 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
A Phase 1 study of Healthy Volunteers and Primary Sclerosing Cholangitis, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
- 1
- Study location
NCT07229911 is a Phase 1 study of Healthy Volunteers and Primary Sclerosing Cholangitis that is actively recruiting participants, run by Takeda. The registered enrollment target is 134 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07229911, a Phase 1 study of Healthy Volunteers and Primary Sclerosing Cholangitis, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
- 1
- Study location
Study Summary
The main aim of this study is to see if the drug TAK-781 is safe for healthy volunteers and for participants with PSC. The study will also look at how well participants can tolerate TAK-781. In addition, the study will check how the body absorbs, uses, and gets rid of TAK-781 (Pharmacokinetics \[PK\]), how the drug affects the body (Pharmacodynamics \[PD\]), and how the body's immune system reacts to TAK-781 (Immunogenicity). The study consists of two phases (Phase 1a and 1b). Phase 1a includes two parts: Part 1 (Single Ascending Dose \[SAD\]) and Part 2 (Multiple Ascending Dose \[MAD\]). In Part 1, healthy participants will receive either single dose of TAK-781 or a placebo. A placebo looks the same as TAK-781 but has no medicine in it. In Part 2, healthy participants will receive multiple doses of TAK-781 or a placebo. In Phase 1b (Part 3), participants with large duct, non-cirrhotic PSC will receive a single dose of TAK-781. Participants will be in the study for about 36 weeks.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-781
Study Locations (1)
Utah
- ICON - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2026-01-07 |
| Est. Completion | 2028-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07229911
The ClinicalTrials.gov registry entry for NCT07229911 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 134 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 (72% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07229911 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT07229911 about?
NCT07229911 is a clinical study titled "A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)". The main aim of this study is to see if the drug TAK-781 is safe for healthy volunteers and for participants with PSC. The study will also look at how well participants can tolerate TAK-781. In addition, the study will check how the body absorbs, uses, and gets rid of TAK-781 (Pharmacokinetics \[PK\...
What is the current status of trial NCT07229911?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2026-01-07. Estimated completion is 2028-04-06.
What conditions does trial NCT07229911 study?
This clinical trial studies the following conditions: Healthy Volunteers, Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT07229911?
The interventions under investigation include: Placebo (DRUG), TAK-781 (DRUG).
Who is sponsoring clinical trial NCT07229911?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07229911 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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