A Clinical Study Evaluating the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients

Haisco Pharmaceutical Group

Status and phase: Active, not recruiting; Phase 2

Conditions: COPD Patients

Treatments: Drug: HSK39004 inhalation suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT07331402

HSK39004-201

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;
• 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];
• 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;
• COPD stable within 4 weeks prior to screening period (Visit 1);
• 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;
• 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;
• Participants voluntarily sign the informed consent form；

Exclusion criteria

• Have a history of life-threatening COPD, including being admitted to the intensive care unit and/or requiring intubation;
• Have received treatment for COPD acute exacerbation for pneumonia within 12 weeks before screening;
• Have a history of or currently have severe cardiovascular diseases;
• Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol/L at screening);
• 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);
• 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;
• 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;
• 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;
• 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;
• 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;
• Pregnant or lactating women, or female subjects with positive pregnancy test results;
• Researchers determine other subjects who are not suitable to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups

HSK39004- Ohtuvayre

Experimental group

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

Treatment:

Drug: HSK39004 inhalation suspension

Ohtuvayre - HSK39004

Other group

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.

Treatment:

Drug: HSK39004 inhalation suspension