Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of Subcutaneous BW-41012 in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BW-41012 when given as a single subcutaneous injection to healthy adults aged 18 to 65 years. This randomized, double-blind, placebo-controlled study includes approximately 40 men and women divided into 5 cohorts to assess different dose levels of BW-41012. Participants will receive a single ascending dose of BW-41012 or placebo via subcutaneous injection. The study is structured into 5 cohorts, each with 8 participants receiving either the investigational drug or placebo. The trial employs a quadruple blinding and parallel assignment model to evaluate the investigational drugs effects compared to placebo. During the study, participants will undergo monitoring for up to 24 hours to assess primary endpoints, with additional evaluations extending up to 8 days and long-term safety follow-up up to 360 days. Assessments include laboratory tests, clinical evaluations, and safety monitoring to track drug effects and tolerability. The total participation duration can last up to nearly one year to ensure comprehensive evaluation of BW-41012.

A Phase 1 Clinical Study in Healthy Participants