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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07011524

Enrollment

200

Registered

2025-06-08

Start date

2025-08-19

Completion date

2027-07-21

Last updated

2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

BIOLOGICALCM512 injection

subcutaneous injection

DRUGPlacebo

subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactQian Jia

qianjia@keymedbio.com028-88610620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026