Study of CM512 Injection in Subjects With Moderate-to-severe Asthma
Recruiting
Phase 2Interventional Study
Asthma
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Keymed Biosciences Co.Ltd · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 75 with moderate-to-severe asthma. Participants will receive either the CM512 injection or a placebo to evaluate its effects on their asthma.
Are You a Good Fit for This Trial?
Must be takingInhaled corticosteroidsAsthma controller medication
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with moderate-to-severe asthma.
I have been treated with medium to high-dose inhaled corticosteroids for at least 3 months.
I have had at least 1 severe asthma attack in the past year.
I have an ACQ-6 score of 1.5 or higher.
I can follow the study instructions and sign a consent form.
You may not be able to join if
I am pregnant or breastfeeding.
I had a positive pregnancy test during screening.
I have a history of drug abuse in the past 5 years.
I am allergic to CM512 or its components.
I have had severe drug allergies or anaphylactic reactions.
I have other medical conditions that prevent me from participating.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 co…
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.
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