Phase 1 Study of TAK-781 in Healthy Adults and Adults With Non-Cirrhotic Primary Sclerosing Cholangitis

What this Trial Is About

Researchers are evaluating the drug TAK-781 to determine its safety, tolerability, and how the body processes it in both healthy volunteers and participants with non-cirrhotic Primary Sclerosing Cholangitis PSC. This Phase 1 study aims to understand how TAK-781 affects the immune system and its pharmacokinetics and pharmacodynamics. The study is sponsored by Takeda and involves detailed monitoring of participants responses to the drug. The study includes two main phases Phase 1a and Phase 1b. In Phase 1a, healthy participants receive either a single dose or multiple doses of TAK-781 or a placebo through injections. Different dose levels and regimens are tested across various cohorts, with some cohorts potentially repeated to assess safety and target engagement. In Phase 1b, participants with large duct, non-cirrhotic PSC receive a single dose of TAK-781. The Phase 1b part only starts after completion of the single ascending dose portion of Phase 1a. Participants will be involved for about 36 weeks, during which they will undergo clinical evaluations including laboratory tests, ECGs, and vital sign monitoring to check for treatment-emergent adverse events and any clinically significant changes. Researchers will also measure drug levels in the blood, immune responses, and fibrosis biomarkers. Safety and tolerability will be carefully monitored throughout the study periods, with follow-up visits to assess ongoing effects and adverse events.

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