Phase 1 Clinical Study of MWX203 Injection in Healthy Subjects

Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of MWX203 Injection in healthy Chinese subjects. The study comprises six dose cohorts with a planned enrollment of 54 subjects. The primary endpoint is safety, assessed by adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. Secondary endpoints include plasma PK parameters, urinary PK parameters, and immunogenicity (anti-drug antibodies).

Timeline

Start

2025-07-07

Primary completion

2026-03-07

Completion

2027-01

Drugs

Indications

No indication recorded.