COPD (Chronic Obstructive Pulmonary Disease)Phase 2NCT07450482
Safety and Efficacy of JKN2304 Inhalation Solution in Patients With Moderate to Severe COPD
A Phase 2 study testing JKN2304 Inhalation Solution and Formoterol Fumarate Inhalation Solution in people with COPD (Chronic Obstructive Pulmonary Disease) and COPD, run by Joincare Pharmaceutical Group Industry Co., Ltd at 8 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), COPD
- What is being tested?
- JKN2304 Inhalation Solution and Formoterol Fumarate Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 8 sitesChina
- Study dates
- 22 Jul 2025to 25 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
- On long-term regular oxygen therapy (>12 hours/day) or mechanical ventilation at screening.
- Initiation of a pulmonary rehabilitation program within 4 weeks prior to screening or planned initiation during the study.
- Use of long-acting bronchodilators (including LABA and LAMA) prior to screening, if judged by the investigator as unable to discontinue for at least 14 days prior to the first dose or during the study.
- Use of inhaled corticosteroids (ICS) prior to screening, meeting any of the following:
- Planning to continue during the study AND dose stable for <28 days prior to the first dose; OR originally on combination ICS and unwilling to switch to an equivalent dose of monotherapy ICS during the study.
- Planning to discontinue during the study AND discontinued for <28 days prior to the first dose.
- Use of oral theophylline or leukotriene inhibitors prior to screening, meeting any of the following:
- Planning to continue during the study AND dose stable for <28 days prior to the first dose.
- Planning to discontinue during the study AND discontinued for less than 5 half-lives of the respective drug prior to the first dose.
- Participation in another clinical trial within 28 days prior to screening or between V1-V3, or within 5 half-lives of the previous investigational drug (whichever is longer; participation defined as having received study drug).
- History of alcohol abuse (weekly intake >14 units: 1 unit ≡ 285 mL beer, 25 mL spirits, or 100 mL wine) or drug abuse within 6 months prior to screening.
- History of psychiatric disorder or cognitive impairment.
- Major surgery within 28 days prior to screening or planned major surgery during the study.
- Female subjects who are lactating or pregnant, or with positive blood HCG at screening.
- Any other condition considered by the investigator as unsuitable for participation in this clinical study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Guangzhou First People's Hospital
Guangzhou, Guangdong
Liuyang People's Hospital
Guankou, Hunan
Jiangyin Hospital of Traditional Chinese Medicine
Jiangyin, Jiangsu
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality
Weifang Second People's Hospital
Weifang, Shandong
The Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu
Zhangzhou Hospital, Fujian Province
Zhangzhou, Fujian
About this study
Official title: 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)
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.
Read the 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:
- JKN2304 Inhalation Solution 2 mg QD (Once Daily): 2 mg active drug in the morning and placebo in the evening.
- JKN2304 Inhalation Solution 2 mg BID (Twice Daily): 2 mg active drug in the morning and 2 mg active drug in the evening.
- Placebo Control: Placebo in the morning and placebo in the evening.
- 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
- Being tested
- JKN2304 Inhalation Solution, Placebo, Formoterol Fumarate Inhalation Solution
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, JKN2304, Moderate to Severe COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKN2304 Inhalation SolutionDrug
Specification: 3ml:2mg. Administered via nebulizer.
PlaceboOther
Specification: 3ml:0mg. Matches the appearance of the investigation product. Administered via nebulizer.
Formoterol Fumarate Inhalation SolutionDrug
Specification: 2ml:20μg. Administered via nebulizer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: JKN2304 Inhalation Solution |
| Placebo | Placebo comparator | Participants receive Placebo (JKN2304 simulator) in the morning and evening via nebulizer for 14 days. Receives: 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) Receives: Drug: Formoterol Fumarate Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From signing of informed consent through the safety follow-up visit (Day 21)
Secondary outcomes (11)
Change from Baseline in FEV1 AUC0-3h
Area Under the Curve (AUC) for Forced Expiratory Volume in 1 second (FEV1) from 0 to 3 hours post-dose.
Measured: Day 14
Change from Baseline in Peak FEV1
Change in maximum FEV1 observed post-dose.
Measured: Day 1 and Day 14
Change from Baseline in Trough FEV1
Trough FEV1 measured at the end of the dosing interval (12 hours post-evening dose for BID regimen, or 24 hours post-dose for QD regimen as applicable per protocol definition).
Measured: Day 1, Day 6, and Day 14
Change from Baseline in FEV1 AUC0-12h and AUC0-24h
Area Under the Curve for FEV1 from 0 to 12 hours and 0 to 24 hours post-dose.
Measured: Day 1 and Day 14
Change from Baseline in COPD Assessment Test (CAT) Score
The COPD Assessment Test (CAT) is a patient-completed questionnaire assessing the impact of COPD on health status. The scale ranges from 0 to 40, where higher scores indicate a worse outcome (greater impact of COPD on the patient's life).
Measured: Day 7 and Day 15
Change from Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale Score
The Modified Medical Research Council (mMRC) Dyspnea Scale assesses the degree of breathlessness. The scale ranges from Grade 0 to Grade 4, where higher grades indicate a worse outcome (more severe breathlessness).
Measured: Day 7 and Day 15
Percentage of Participants Using Rescue Medication
Proportion of participants requiring Salbutamol Sulfate Aerosol for rescue therapy.
Measured: Up to Day 14
Area Under the Plasma Concentration-Time Curve (AUC) of JKN2304
Area under the plasma concentration-time curve from time zero to the end of the dosing interval at steady state (AUC0-t).
Measured: Day 1 and Day 13-15 (per sampling schedule)
Maximum Plasma Concentration (Cmax) of JKN2304
Peak plasma concentration of JKN2304 observed at steady state.
Measured: Day 1 and Day 13-15 (per sampling schedule)
Time to Maximum Plasma Concentration (Tmax) of JKN2304
Time from drug administration to maximum observed plasma concentration at steady state.
Measured: Day 1 and Day 13-15 (per sampling schedule)
Trough Plasma Concentration (Ctrough) of JKN2304
Plasma concentration of JKN2304 measured at the end of the dosing interval (trough).
Measured: Day 1 and Day 13-15 (per sampling schedule)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start22 Jul 2025
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Livzon Pharmaceutical Group Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450482
- Sponsor's protocol ID
- JKN2304-IIa-02
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) and supporting clinical documents from this Phase IIa study will not be made publicly available. The decision is based on the following considerations: 1) The data are preliminary and derived from a small, exploratory study, intended primarily for internal research and development and regulatory submission purposes. 2) The dataset contains detailed participant-level information that could compromise participant privacy and confidentiality. 3) Data sharing is restricted in accordance with applicable privacy laws and regulations in China. Future data sharing policies for subsequent phases of the clinical development program may be re-evaluated.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07450482
- Acronym / sponsor ID
- JKN2304-IIa-02
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), COPD
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, JKN2304, Moderate to Severe COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Livzon Pharmaceutical Group Inc.
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- JKN2304 Inhalation Solution 2 mg QD (Once Daily): 2 mg active drug in the morning and placebo in the evening.
- JKN2304 Inhalation Solution 2 mg BID (Twice Daily): 2 mg active drug in the morning and 2 mg active drug in the evening.
- Placebo Control: Placebo in the morning and placebo in the evening.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JKN2304 2 mg QD | Experimental | Drug: JKN2304 Inhalation Solution, Other: PlaceboParticipants receive JKN2304 Inhalation Solution 2 mg in the morning and Placebo in the evening via nebulizer for 14 days. |
| JKN2304 2 mg BID | Experimental | Drug: JKN2304 Inhalation SolutionParticipants receive JKN2304 Inhalation Solution 2 mg in the morning and JKN2304 Inhalation Solution 2 mg in the evening via nebulizer for 14 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive Placebo (JKN2304 simulator) in the morning and evening via nebulizer for 14 days. |
| Formoterol Fumarate | Active comparator | Drug: Formoterol Fumarate Inhalation SolutionParticipants receive Formoterol Fumarate Inhalation Solution 20 μg twice daily (morning and evening) via nebulizer for 14 days. (Open-label) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JKN2304 Inhalation SolutionSpecification: 3ml:2mg. Administered via nebulizer. | Drug | JKN2304 2 mg BID, JKN2304 2 mg QD |
| PlaceboSpecification: 3ml:0mg. Matches the appearance of the investigation product. Administered via nebulizer. | Other | JKN2304 2 mg QD, Placebo |
| Formoterol Fumarate Inhalation SolutionSpecification: 2ml:20μg. Administered via nebulizer. | Drug | Formoterol Fumarate |
Primary outcome
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From signing of informed consent through the safety follow-up visit (Day 21)
Assessment of safety including adverse events, laboratory tests (hematology, blood biochemistry, urinalysis), electrocardiogram (ECG), vital signs, physical examinations, and oropharyngeal examinations.
11 secondary outcomes
Change from Baseline in FEV1 AUC0-3h
Time frame: Day 14
Change from Baseline in Peak FEV1
Time frame: Day 1 and Day 14
Change from Baseline in Trough FEV1
Time frame: Day 1, Day 6, and Day 14
Change from Baseline in FEV1 AUC0-12h and AUC0-24h
Time frame: Day 1 and Day 14
Change from Baseline in COPD Assessment Test (CAT) Score
Time frame: Day 7 and Day 15
Change from Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale Score
Time frame: Day 7 and Day 15
Percentage of Participants Using Rescue Medication
Time frame: Up to Day 14
Area Under the Plasma Concentration-Time Curve (AUC) of JKN2304
Time frame: Day 1 and Day 13-15 (per sampling schedule)
Maximum Plasma Concentration (Cmax) of JKN2304
Time frame: Day 1 and Day 13-15 (per sampling schedule)
Time to Maximum Plasma Concentration (Tmax) of JKN2304
Time frame: Day 1 and Day 13-15 (per sampling schedule)
Trough Plasma Concentration (Ctrough) of JKN2304
Time frame: Day 1 and Day 13-15 (per sampling schedule)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) and supporting clinical documents from this Phase IIa study will not be made publicly available. The decision is based on the following considerations: 1) The data are preliminary and derived from a small, exploratory study, intended primarily for internal research and development and regulatory submission purposes. 2) The dataset contains detailed participant-level information that could compromise participant privacy and confidentiality. 3) Data sharing is restricted in accordance with applicable privacy laws and regulations in China. Future data sharing policies for subsequent phases of the clinical development program may be re-evaluated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JKN2304 Inhalation Solution and Formoterol Fumarate Inhalation Solution in people with COPD (Chronic Obstructive Pulmonary Disease) and COPD, run by Joincare Pharmaceutical Group Industry Co., Ltd at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From signing of informed consent through the safety follow-up visit (Day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.