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

Keymed Biosciences

Status and phase

Enrolling

Phase 2

Conditions

Asthma

Treatments

Biological: CM512 injection

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07011524

CM512-103101

Details and patient eligibility

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.