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Phase 1 Clinical Study of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
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.
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2026-03-19
Completion Date
2026-12
Last Updated
2026-09-04
Healthy Volunteers
Yes
Conditions
Interventions
MWX401 1
Administered subcutaneously (SC)
MWX401 2
Administered SC
MWX401 3
Administered SC
MWX401 4
Administered SC
MWX401 5
Administered SC
Placebo
Administered SC
Locations (1)
The Affiliated Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, China