Study of CM512 Injection in Subjects With Moderate-to-severe Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CM512 injection
Biological/Vaccinesubcutaneous injection
Placebo
Drugsubcutaneous injection
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from the baseline in Forced Expiratory Volume in one second (FEV1)
Change from baseline in pre-bronchodilator FEV1 in each dose group at 12 weeks of CM512 treatment compared with placebo.
Time frame
Up to week 12Sponsors and contacts
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Source ClinicalTrials.gov