Actively Recruiting
Study of CM512 Injection in Subjects With Moderate-to-severe Asthma
Led by Keymed Biosciences Co.Ltd · Updated on 2025-08-28
200
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with moderate-to-severe asthma.
CONDITIONS
Official Title
Study of CM512 Injection in Subjects With Moderate-to-severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.
- Age 25 18 years old and 24 75 years old.
- Body mass index (BMI) 25 18.0 kg/(m*m).
- Documented treatment with medium to high dose Inhaled Corticosteroids (ICS) in combination with asthma controller medication for at least 3 months with a stable dose 251 month prior to Visit 1.
- Documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
- Asthma Control Questionnaire-6 (ACQ-6) score 251.5
You will not qualify if you...
- Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
- With a history of drug abuse within the past 5 years before screening visit.
- Allergic or intolerant to CM512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock.
- With any medical or non-medical conditions that are not suitable for participation in this study by investigators.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Clinical Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Q
Qian Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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