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COMPLETED
NCT07801313
PHASE1

Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, placebo-controlled, single-dose and multiple-dose, dose-escalation phase I clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of MWN105 injection in healthy Chinese volunteers, and to provide a reference for the next clinical trial. This study includes a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. The SAD study consists of 4 dose groups; the MAD study consists of 2 dose groups and adopts a 4-week dose titration scheme. The study plans to enroll 55 volunteers. The primary endpoint is the incidence of adverse events. The secondary endpoints are the pharmacokinetic and pharmacodynamic characteristics and immunogenicity endpoints.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Ascending Doses of MWN105 Injection in Healthy Chinese Volunteers

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2024-12-19

Completion Date

2025-07-20

Last Updated

2026-09-03

Healthy Volunteers

Yes

Interventions

DRUG

MWN105

S1, S2 S3, S4; administered subcutaneously (SC)

DRUG

MWN105

M1, M2; administered SC

DRUG

Placebo

administered SC

Locations (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China