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RECRUITING
NCT07803835
PHASE1

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

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

MWX401 1

Administered subcutaneously (SC)

DRUG

MWX401 2

Administered SC

DRUG

MWX401 3

Administered SC

DRUG

MWX401 4

Administered SC

DRUG

MWX401 5

Administered SC

DRUG

Placebo

Administered SC

Locations (1)

The Affiliated Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, China