Phase 1 Clinical Study of MWN109 Injection in Healthy Chinese Volunteers

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
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 healthyChinese volunteers and to provide data for subsequent clinical trials.The study includes a single ascending dose (SAD) part with 4 dose cohorts and a multipleascending 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 byadverse events, serious adverse events, vital signs, physical examinations, laboratorytests, and 12‐lead electrocardiograms. The secondary endpoint is the pharmacokineticcharacteristics.
Epistemonikos ID: 7a0677b5780fe9ede2717c3b9cf0ad3187282f9f
First added on: Aug 26, 2026