Phase II Study of RC1416 Injection in COPD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorNanjing RegeneCore Biotech Co., Ltd.
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Eligibility criteria
Qualifiers
Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.
Body Mass Index (BMI) ≥ 16 kg/m².
Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening.
Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) < 0.7, and post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted value at screening.
Disqualifiers
A current diagnosis of asthma or a history of asthma.
Presence of other significant pulmonary diseases except COPD as judged by the Investigator.
History of malignancy .
A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form.
Trial design
Treatments tested in this trial
- RC1416
- RC1416 Placebo
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov