Phase IIa Study of JKN2403 Tablets to Treat Moderate-to-Severe COPD in Adults Evaluating Effectiveness, Safety, and Pharmacokinetics Compared to Placebo

What this Trial Is About

Researchers are evaluating the drug JKN2403 in adults with moderate-to-severe chronic obstructive pulmonary disease COPD. The study aims to see if JKN2403 reduces the number of flare-ups acute exacerbations or improves quality of life and symptoms related to COPD. This phase IIa trial will also study the safety and how the body processes JKN2403, comparing it to a placebo that contains no active drug. Participants will be randomly assigned to one of four groups three different doses of JKN2403 tablets taken once daily by mouth for 24 weeks, or a placebo taken once daily for 24 weeks. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Regular clinic visits will happen every four weeks during the treatment period. During the trial, participants will have checkups and tests at each visit, keep a diary of their symptoms, and record how often they use rescue inhalers. Researchers will measure flare-up rates, lung function using pre-bronchodilator FEV1, quality of life scores, and time to first flare-up over the treatment period. The study plans to follow participants for up to 24 months to assess these outcomes and monitor safety.

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD