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ACTIVE NOT RECRUITING
NCT07799025
PHASE1

Phase 1 Clinical Study of MWX203 Injection in Healthy Subjects

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

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).

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Administration of MWX203 Injection in Healthy Chinese Subjects

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-07-07

Completion Date

2027-01

Last Updated

2026-09-02

Healthy Volunteers

Yes

Interventions

DRUG

MWX203 S1

administered subcutaneously (SC)

DRUG

Placebo

administered SC

DRUG

MWX203 S2

administered SC.

DRUG

MWX203 S3

administered SC.

DRUG

MWX203 S4

administered SC.

DRUG

MWX203 S5

administered SC.

DRUG

MWX203 S6

administered SC.

Locations (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China