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

Phase 2

Recruiting

• Conditions: Asthma
• Interventions: Biological: CM512 injection; Drug: Placebo

• Registration Number: NCT07011524
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-08
• Study Start: 2025-08-19
• Last Update Submitted: 2025-08-21
• Last Update Posted: 2025-08-28
• Primary Completion: 2027-07-21
• Study Completion: 2027-07-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	CM512 injection	-
Group 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from the baseline in Forced Expiratory Volume in one second (FEV1)	Up to week 12	Change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM512 treatment compared with placebo.

Trial Locations

Locations (1)

The First Clinical Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China