A Study of CM310 in Subjects With Moderate to Severe Asthma

Recruiting Phase 2 Phase 3 Interventional Study
Moderate to Severe Asthma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 75
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Have the ability to understand the study and voluntarily sign the informed consent form. 2. Age ≥12 and ≤75 years old, male or female, weight ≥40 kg. 3. The subject has been diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteri…
Contacts

Wang Wenjuan

010-63942533

wangwenjuan01@cspc.cn

CONTACT