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

NCT07450482 | Completed Phase 2

• 1 other identifier: JKN2304-IIa-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 8

Brief 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; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Chronic Obstructive Pulmonary Disease; JKN2304; Moderate to Severe COPD

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Assessment of safety including adverse events, laboratory tests (hematology, blood biochemistry, urinalysis), electrocardiogram (ECG), vital signs, physical examinations, and oropharyngeal examinations.

  From signing of informed consent through the safety follow-up visit (Day 21)

Secondary Outcomes (11)

• Change from Baseline in FEV1 AUC0-3h

  Day 14

• Change from Baseline in Peak FEV1

  Day 1 and Day 14

• Change from Baseline in Trough FEV1

  Day 1, Day 6, and Day 14

• Change from Baseline in FEV1 AUC0-12h and AUC0-24h

  Day 1 and Day 14

• Change from Baseline in COPD Assessment Test (CAT) Score

  Day 7 and Day 15

Study Arms (4)

JKN2304 2 mg QD

EXPERIMENTAL

Participants receive JKN2304 Inhalation Solution 2 mg in the morning and Placebo in the evening via nebulizer for 14 days.

Drug: JKN2304 Inhalation Solution; Other: Placebo

JKN2304 2 mg BID

EXPERIMENTAL

Participants receive JKN2304 Inhalation Solution 2 mg in the morning and JKN2304 Inhalation Solution 2 mg in the evening via nebulizer for 14 days.

Drug: JKN2304 Inhalation Solution

Placebo

PLACEBO COMPARATOR

Participants receive Placebo (JKN2304 simulator) in the morning and evening via nebulizer for 14 days.

Other: Placebo

Formoterol Fumarate

ACTIVE COMPARATOR

Participants receive Formoterol Fumarate Inhalation Solution 20 μg twice daily (morning and evening) via nebulizer for 14 days. (Open-label)

Drug: Formoterol Fumarate Inhalation Solution

Interventions

Formoterol Fumarate Inhalation Solution DRUG

Specification: 2ml:20μg. Administered via nebulizer.

Formoterol Fumarate

JKN2304 Inhalation Solution DRUG

Specification: 3ml:2mg. Administered via nebulizer.

JKN2304 2 mg BID; JKN2304 2 mg QD

Placebo OTHER

Specification: 3ml:0mg. Matches the appearance of the investigation product. Administered via nebulizer.

JKN2304 2 mg QD; Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and comply with the trial procedures, voluntarily participate, and sign the informed consent form.
• Age between 40 and 75 years (inclusive) at the time of signing the informed consent, both males and females.
• History of exposure to COPD risk factors, such as: smoking history ≥10 pack-years (pack-years = \[number of cigarettes per day / 20\] x years smoked; use of electronic cigarettes, pipes, or cigars cannot be used to calculate pack-years), or exposure to biomass fuel for ≥10 years.
• Established diagnosis of COPD according to the GOLD 2024 guidelines prior to screening.
• History of ≥1 severe Acute Exacerbation of COPD (AECOPD) leading to hospitalization OR ≥2 moderate AECOPDs within 12 months prior to screening; OR, if ≤1 moderate AECOPD within 12 months prior to screening, then baseline mMRC score must be ≥2 and CAT score ≥10.
• No occurrence of AECOPD within the 4 consecutive weeks prior to screening.
• Post-bronchodilator (400 µg salbutamol) FEV1/FVC \< 0.70, and post-bronchodilator FEV1 percent predicted (ppFEV1) between 30% and 79%.
• Ability to perform acceptable and reproducible spirometry.
• Compliance with concomitant medication restrictions (see study protocol section 5.6) and expected to maintain these restrictions during the treatment period.
• For subjects of childbearing potential (or with partners of childbearing potential), willingness to use effective contraception from signing the informed consent until 3 months after the last dose.

You may not qualify if:

• History of hypersensitivity to the investigational drug or drugs of the same class, or history of bronchospasm.
• Current diagnosis of bronchial asthma.
• Current diagnosis of other lung diseases that may impair lung function, including but not limited to: alpha-1 antitrypsin deficiency, cystic fibrosis, bronchiectasis, bronchiolitis obliterans, bronchopulmonary dysplasia, active pulmonary tuberculosis, pulmonary hypertension (except if judged by the investigator to be due to COPD), interstitial lung disease (e.g., pulmonary fibrosis), pneumothorax, etc.
• Acute lower respiratory tract infection within 4 weeks prior to or during screening.
• Hospitalization for respiratory disease within 4 weeks prior to or during screening.
• Clinically significant history of cardiovascular/cerebrovascular disease within 6 months prior to screening, such as congestive heart failure, acute coronary syndrome (including acute myocardial infarction and unstable angina), newly diagnosed atrial fibrillation, supraventricular/ventricular tachycardia, aortic aneurysm, stroke, etc.
• Poorly controlled hypertension within 6 months prior to screening (defined as failure to achieve target blood pressure despite combination therapy with ≥3 antihypertensive agents) OR confirmed systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg during screening upon repeated measurement; severe arrhythmia requiring antiarrhythmic drug therapy; sinus node dysfunction, Mobitz type II or third-degree atrioventricular block without a pacemaker.
• Narrow-angle glaucoma, bladder neck obstruction, moderate-to-severe prostatic hyperplasia, or history of acute urinary retention, judged by the investigator as a contraindication to inhaled anticholinergic drugs.
• Any active malignancy or history of malignancy within 5 years prior to screening, except for cured cancers (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, localized low-risk prostate cancer, papillary thyroid carcinoma) and radically resected carcinoma in situ (e.g., ductal carcinoma in situ of the breast, cervical carcinoma in situ).
• Laboratory values at screening meeting any of the following:
• Neutrophil count (NEUT) \< 1.5 x 10\^9/L
• ALT \> 2.5 x ULN OR AST \> 2.5 x ULN OR Total Bilirubin \> 1.5 x ULN
• Creatinine (Cr) \> 1.5 x ULN
• History of long QT syndrome, or QTc \> 480 ms at screening (calculated using Fridericia's formula: QTc = QT / RR\^0.33).
• History of lung resection surgery, or lung volume reduction surgery within 12 months prior to screening.

Sponsors & Collaborators

• Joincare Pharmaceutical Group Industry Co., Ltd: lead
• Livzon Pharmaceutical Group Inc.: collaborator

Study Sites (8)

Zhangzhou Hospital, Fujian Province

Zhangzhou, Fujian, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Location

Liuyang People's Hospital

Guankou, Hunan, China

Location

Jiangyin Hospital of Traditional Chinese Medicine

Jiangyin, Jiangsu, China

Location

The Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Location

Weifang Second People's Hospital

Weifang, Shandong, China

Location

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: open-label for the active comparator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: March 4, 2026
• Study Start: July 22, 2025
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)