RecruitingPhase 2NCT07011524

Study of CM512 Injection in Subjects With Moderate-to-severe Asthma

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With Moderate-to-severe Asthma.

Sponsor

Keymed Biosciences Co.Ltd

Enrollment

200 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Asthma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.
Age ≥ 18 years old and ≤ 75 years old.
Body mass index (BMI) ≥ 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 ≥1 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 ≥1.5

Exclusion Criteria4

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.