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RECRUITING
NCT07351734
PHASE2

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

Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if drug JKN2403 works to treat moderate-to-severe COPD in adults. It will also learn about the safety and pharmacokinetic characteristics of drug JKN2403. The main questions it aims to answer are: Does drug JKN2403 reduce the incidence of AECOPD or improve the quality of life or alleviate symptoms related to COPD? Researchers will compare drug JKN2403 to a placebo (a look-alike substance that contains no drug) to see if drug JKN2403 works to treat moderate-to-severe COPD. Participants will: Take drug JKN2403 or a placebo every day for 24 weeks Visit the clinic once every four weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler

Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of JKN2403 Tablets in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-11-06

Completion Date

2026-09-30

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

JKN2403 Tablets

JKN2403 Tablets once daily orally, for 24 weeks

DRUG

Placebo

Placebo

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China