Phase 1 Study of Subcutaneous BW-50218 Injection Evaluating Safety and Effects in Healthy Adults

What this Trial Is About

This research aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called BW-50218 when given as a single subcutaneous injection to healthy adults. It is a Phase 1, randomized, double-blind, placebo-controlled study involving healthy participants aged 18 to 65 years. The study is sponsored by Shanghai Argo Biopharmaceutical Co., Ltd. and intends to assess the effects of the drug compared to a saline placebo. Participants receive a single dose of BW-50218 subcutaneously at one of six increasing dose levels or a saline placebo injection. The study uses a parallel design where participants are randomly assigned to one of these groups. The trial includes close monitoring for up to 360 days after dosing to evaluate safety and drug behavior in the body. During the study, participants will undergo various assessments including monitoring for adverse events, clinical laboratory tests, vital signs, electrocardiograms ECG, and physical examinations from baseline up to one year. Pharmacokinetic measures such as plasma concentration and elimination half-life will be collected up to 8 days post-dose. Participants are expected to comply with study procedures and contraception requirements to ensure safety throughout the trial.

Study of BW-50218 in Healthy Participants