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Phase 1 Clinical Study of MWX203 Injection in Healthy Subjects

Shanghai Minwei Biotechnology Co., Ltd · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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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).
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