Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:19 AM
Study NCT ID:
NCT07331402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study Evaluating the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-30', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Cmax after single administrations', 'timeFrame': '[Time Frame: From the start of administration to 12 hours post-dose]', 'description': 'The Cmax of HSK39004 in plasma'}, {'measure': 'The Css(max) after multiple administrations (steady state)', 'timeFrame': '[Time Frame: From the start of administration to 7 days post-dose]', 'description': 'The Css(max) of HSK39004 in plasma'}], 'secondaryOutcomes': [{'measure': 'The ΔFEV1 AUC0-12h', 'timeFrame': '[Time Frame: From the start of administration to 12 hours post-dose on Day1 and Day7]', 'description': 'The area under the curve of FEV1 change from baseline from 0 to 12 hours after administration'}, {'measure': 'AEs', 'timeFrame': '[Time Frame: From the time of signing ICF to the end of follow-up，up to 7 days after the last administration]', 'description': 'The incidence and severity of AEs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD Patients']}, 'descriptionModule': {'briefSummary': 'This is a random, single blind, positive control, crossover design clinical study to evaluate the pharmacokinetics and pharmacodynamics of HSK39004 inhalation suspension in COPD patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;\n* The subjects with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year \\[GOLD 2025 standard: the subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) \\<0.7\\];\n* During the screening visit (Visit 1):· FEV1/FVC after using bronchodilators is \\<0.7;· 30% of the expected value ≤ FEV1 after using bronchodilators \\< 80% of the expected value;\n* COPD stable within 4 weeks prior to screening period (Visit 1);\n* During the screening period and treatment period, COPD drugs prohibited by the protocol (except for salbutamol inhalation aerosol as a rescue drug) can be discontinued;\n* Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or quit smoking for more than 6 months, or those with a history of exposure to other risk factors;\n* Participants voluntarily sign the informed consent form；\n\nExclusion Criteria:\n\n* Have a history of life-threatening COPD, including being admitted to the intensive care unit and/or requiring intubation;\n* Have received treatment for COPD acute exacerbation for pneumonia within 12 weeks before screening;\n* Have a history of or currently have severe cardiovascular diseases;\n* Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol/L at screening);\n* Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors);\n* Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease/abnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results;\n* During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects;\n* Allergy to HSK39004 inhalation powder or salbutamol or any known components in the administration system ; 8. Before the pulmonary function test during the screening (visit 1), any prohibited drugs in the protocol were used;\n* During the screening period, there were clinically significant abnormalities in the 12 lead electrocardiogram that were determined by the researchers to be potentially risky for the subjects;\n* Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study;\n* Pregnant or lactating women, or female subjects with positive pregnancy test results;\n* Researchers determine other subjects who are not suitable to participate.'}, 'identificationModule': {'nctId': 'NCT07331402', 'briefTitle': 'A Clinical Study Evaluating the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Random, Single Blind, Positive Control, Crossover Design Clinical Study to Evaluate the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients', 'orgStudyIdInfo': {'id': 'HSK39004-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK39004- Ohtuvayre', 'description': 'The first period, HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; The second period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day', 'interventionNames': ['Drug: HSK39004 inhalation suspension']}, {'type': 'OTHER', 'label': 'Ohtuvayre - HSK39004', 'description': 'The first period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day; The second period，HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day.', 'interventionNames': ['Drug: HSK39004 inhalation suspension']}], 'interventions': [{'name': 'HSK39004 inhalation suspension', 'type': 'DRUG', 'otherNames': ['Ohtuvayre inhalation suspension'], 'description': 'HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day', 'armGroupLabels': ['HSK39004- Ohtuvayre', 'Ohtuvayre - HSK39004']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': '36 Sanhao Street, Heping District, Shenyang, Liaoning,China', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haisco Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}