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

NCT07450482 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)
  • COPD

Interventions

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.

Sponsors & Collaborators

  • Livzon Pharmaceutical Group Inc.

    collaborator INDUSTRY

  • Joincare Pharmaceutical Group Industry Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2025-09-25
Completion
2025-09-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07450482 on ClinicalTrials.gov