A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorKeymed Biosciences Co.Ltd
About this trial
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Explore the Efficacy and Safety of CM512 Injection in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Eligibility criteria
Qualifiers
40 to ≤ 80 years old
BMI ≥ 18.0 kg/(m*m)
COPD diagnosis≥1 year
Post-BD FEV1 ≥ 30% and < 80%, FEV1/FVC <0.70 at screening
Disqualifiers
Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
Treatment with oxygen of more than 15 hours per day.
Pregnant or breastfeeding.
Trial design
Treatments tested in this trial
- CM512
- Placebo
Treatment groups
204 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov