NCT07418736

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

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）

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	CM326 dose 1	subcutaneous injection
DRUG	CM326 dose 2	subcutaneous injection
OTHER	Placebo	subcutaneous injection

Timeline

• Start date: 2025-12-18
• Primary completion: 2027-07-01
• Completion: 2027-10-10
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: China