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A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
NCT07229911 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07229911 reports 1 study location spanning 1 distinct geographic area — top geographies include Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07229911?
The interventions under investigation include: Placebo (DRUG), TAK-781 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07229911?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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