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

August 21, 2025 updated by: Keymed Biosciences Co.Ltd

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Clinical Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Biological: CM512 injection
subcutaneous injection
Placebo Comparator: Group 2
Drug: Placebo
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Ruchong Chen, The First Clinical Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2025

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

July 21, 2027

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

June 5, 2025

First Posted (Actual)

June 8, 2025

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM512-103101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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