Phase 1 Clinical Study of MWN109 Injection in Healthy Chinese Volunteers

This is a randomized, double-blind, placebo-controlled, single- and multiple- dose-escalating Phase 1a study. The objective is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN109 Injection in healthy Chinese volunteers and to provide data for subsequent clinical trials. The study includes a single ascending dose (SAD) part with 4 dose cohorts and a multiple ascending dose (MAD) part with 3 dose cohorts, using a 3-week dose titration regimen. Approximately 58 volunteers will be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.