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Phase 1 Clinical Study of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension

StatusRecruiting
PhasePhase 1
Started2026-03-19
View on ClinicalTrials.gov ↗
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase 1 clinical study, aimed at evaluating the safety, tolerability, PK, PD and immunogenicity of single subcutaneous administration of MWX401 Injection in healthy Chinese participants and participants with primary mild hypertension. The study comprises five dose cohorts with a planned enrollment of 46 subjects. The primary endpoint is the incidence and severity of treatment-emergent adverse events. Secondary endpoints include plasma and urinary PK parameters, changes in serum AGT and RAAS components, changes in blood pressure and hemodynamics, and immunogenicity indicators.
Trial Details
NCT Number NCT07803835
Lead Sponsor Shanghai Minwei Biotechnology Co., Ltd
Conditions Essential Hypertension, Healthy Volunteers
Enrollment 46 participants
Start Date 2026-03-19
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-04