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RECRUITING
NCT07418736
PHASE2

A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease. The study consists of a screening period of up to 4 weeks, a randomized treatment period of 24 to 52 weeks, and a 12-week safety follow-up period.

Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM326 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease(COPD)

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

318

Start Date

2025-12-18

Completion Date

2027-10-10

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DRUG

CM326 dose 1

subcutaneous injection

DRUG

CM326 dose 2

subcutaneous injection

OTHER

Placebo

subcutaneous injection

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China