drugset / Trial / NCT06547333

A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT06547333

Phase 2/3 Not yet recruiting 884 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ/Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe Chronic Obstructive Pulmonary Disease(COPD). The study has two parts. Each part consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 8-week safety follow-up period.

Timeline

Start
2024-09-13
Primary completion
2032-04-29
Completion
2032-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CM310 Monoclonal antibody 150 mg Subcutaneous
Subject CM310 Monoclonal antibody 300 mg Subcutaneous