NCT07011524RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 28 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 19 Aug 2025
- Primary completion date
- 21 Jul 2027
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Asthma
- NCT number
- NCT07011524
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 19 Aug 2025 to the primary completion date, 21 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Clinical Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.