NCT07450482

Safety and Efficacy of JKN2304 Inhalation Solution in Patients With Moderate to Severe COPD

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled (Open-Label), Phase IIa Clinical Study to Evaluate the Safety and Efficacy of JKN2304 Inhalation Solution in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase IIa study is to evaluate the safety, efficacy, and pharmacokinetics of JKN2304 Inhalation Solution in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study is a multicenter, randomized, double-blind, placebo-controlled, and active-controlled (open-label) trial. Participants are randomized to receive JKN2304 (2 mg once daily or 2 mg twice daily), Placebo, or Formoterol Fumarate Inhalation Solution for a treatment period of 14 days.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, and active-controlled (open-label for the active comparator) Phase IIa clinical study. The study aims to enroll approximately 40 patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD). The study consists of three periods: a Screening Period (up to 28 days), a Treatment Period (14 days), and a Follow-up Period (7 days). During the Screening Period, patients undergo wash-out of prohibited medications (e.g., LAMA withdrawn for at least 7 days, LABA for at least 48 hours prior to the reversibility test). Eligible participants are randomized in a 1:1:1:1 ratio to one of the following four treatment arms: 1. JKN2304 Inhalation Solution 2 mg QD (Once Daily): 2 mg active drug in the morning and placebo in the evening. 2. JKN2304 Inhalation Solution 2 mg BID (Twice Daily): 2 mg active drug in the morning and 2 mg active drug in the evening. 3. Placebo Control: Placebo in the morning and placebo in the evening. 4. Active Control: Formoterol Fumarate Inhalation Solution 20 μg BID (Open-label). The primary objective is to evaluate the safety of JKN2304 in COPD patients. Secondary objectives include evaluating the efficacy (assessed by pulmonary function tests such as FEV1) and characterizing the pharmacokinetic (PK) profile of JKN2304. Safety assessments are conducted throughout the study. Efficacy assessments, including pulmonary function tests, are performed at designated time points (e.g., Day 1 and Day 14). A safety follow-up visit is conducted on Day 21 (7 days after the last dose).

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)
• COPD

Interventions

Type	Name	Description
DRUG	JKN2304 Inhalation Solution	Specification: 3ml:2mg. Administered via nebulizer.
OTHER	Placebo	Specification: 3ml:0mg. Matches the appearance of the investigation product. Administered via nebulizer.
DRUG	Formoterol Fumarate Inhalation Solution	Specification: 2ml:20μg. Administered via nebulizer.

Timeline

• Start date: 2025-07-22
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

8 sites across 1 country: China