drugset / Trial / NCT06547333
A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CM310 | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | CM310 | Monoclonal antibody | 300 mg | Subcutaneous |