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
Qualifiers
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
Treatments tested in this trial
- CM512 injection
- Placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov