Evaluating RC1416 Injection in Adults Aged 40 to 85 with Moderate to Severe COPD A Randomized, Placebo-Controlled Phase II Trial

What this Trial Is About

Researchers are conducting a phase II clinical trial to evaluate the safety and effectiveness of RC1416 injection in adults aged 40 to 85 with moderate to severe chronic obstructive pulmonary disease COPD. The study is randomized, double-blind, and placebo-controlled, aiming to better understand treatment options for patients with this lung condition. The trial is sponsored by Nanjing RegeneCore Biotech Co., Ltd. Participants will receive either the RC1416 drug or a placebo through subcutaneous injections every two weeks for a year. The study focuses on two doses of RC1416 and compares them against placebo to assess impacts on COPD exacerbations and lung function. Treatment continues for 52 weeks under close medical supervision. Throughout the study, participants will undergo regular assessments including lung function tests such as forced expiratory volume in 1 second FEV1, and measurements of biomarkers like FeNO, total IgE, eosinophil count, and TARC levels. Safety, tolerability, pharmacokinetics, and immunogenicity will also be monitored. The trials total duration for treatment and evaluation is one year, with careful tracking of participants health and response to the study drug.

Phase II Study of RC1416 Injection in COPD