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

NCT07803835 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

  • Essential Hypertension
  • Healthy Volunteers

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

Sponsors & Collaborators

  • Shanghai Minwei Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803835 on ClinicalTrials.gov