A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-50218 in Healthy Participants

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called BW-50218 administered by subcutaneous injection in healthy adults. This is a Phase 1, randomized, double-blind, placebo-controlled study designed to assess how the drug behaves in the body and its potential effects compared to a placebo. The study is conducted by Shanghai Argo Biopharmaceutical Co., Ltd. and involves healthy participants aged 18 to 65. Participants receive a single dose of BW-50218 at one of six different dose levels or a saline placebo injection. Each participant receives only one injection during the study. The trial includes a randomized assignment to different dose groups or placebo, and the study is double-blind, meaning neither the participants nor the investigators know which treatment is administered. The study period covers a follow-up lasting up to 360 days after dosing to monitor effects. During the study, participants undergo regular assessments including monitoring for adverse events and serious adverse events, vital signs, physical exams, 12-lead ECG evaluations, and laboratory tests. Researchers measure drug levels in plasma and urine, as well as changes in serum transthyretin protein concentration. The study aims to track safety and pharmacological effects over the course of up to one year after dosing, requiring participants to comply with scheduled visits and procedures throughout this time.

Study of BW-50218 in Healthy Participants