RecruitingPhase 1NCT07229911

A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Sponsor-Open Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-781 in Healthy Participants and a Single-Arm, Open-Label Evaluation in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis


Sponsor

Takeda

Enrollment

134 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 68 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called TAK-781 for people with healthy volunteers and primary sclerosing cholangitis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTAK-781

TAK-781 injection.

DRUGPlacebo

TAK-781 matching placebo injection.


Locations(1)

ICON

Salt Lake City, Utah, United States

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NCT07229911


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