NCT05761028

A Study of CM310 in Subjects With Moderate to Severe Asthma

A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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 asthma. The study consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 4-week safety follow-up period.

Conditions

• Moderate to Severe Asthma

Interventions

Type	Name	Description
DRUG	CM310	CM310 Recombinant Humanized Monoclonal Antibody Injection
OTHER	Placebo	Placebo

Timeline

• Start date: 2023-04-28
• Primary completion: 2032-05-01
• Completion: 2032-05-01
• First posted: 2023-03-09
• Last updated: 2023-12-15

Locations

1 site across 1 country: China