Healthy Donors
Conditions
Brief summary
To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy of HSK39004 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease（COPD）.
Interventions
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* For healthy volenteers: 1. Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions; 2. 18 years to 45 years (inclusive), male and female; 3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-26 kg/m2 (inclusive) ; 4. Ability to perform acceptable and reproducible spirometry; 5. Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values; 6. Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration. * For COPD patients: 1. Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions; 2. Age ≥ 40 years , male and female; 3. According to the diagnostic criteria of 2024 Practical Edition of Guidelines , the patient was diagnosed with COPD; The patient has chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or a history of exposure to risk factors, and the results of pulmonary function tests show that post-bronchodilator spirometry demonstrate FEV1/FVC ratio of ≤0.70 ; 4. At screening: post-bronchodilator spirometry demonstrate FEV1/FVC ratio of ≤0.70 and FEV1 must be ≥40 % to ≤80% of predicted normal and FEV1 increased by ≥100ml compared with pre-bronchiectasis; 5. No regular treatment of COPD was performed before joining the study. COPD agents (except SABA and/or SAMA) that are contraindicated in the protocol may be discontinued during the screening and treatment; 6. Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
Exclusion criteria
* For healthy volenteers: 1. Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening; 2. Have a history of any malignant tumors; 3. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance (only for healthy subjects); 4. Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion; 5. Acute respiratory infections occurred within 6 weeks before screening and/or before randomization; 6. Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration; 7. Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study (only for healthy subjects); 8. Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening; 9. Have a history of drug abuse prior to screening, or positive urine drug screen at screening (If COPD patients were false positives due to other medications, they can be retested after the medication is washed); 10. Blood donation (or blood loss) ≥400 mL within 3 months prior to the screening; 11. Subjects who have a allergic to any component of HSK39004 or allergic history to opiates; 12. Intolerance to this product or the same target drug; 13. Subjects who use any live vaccine within 30 days prior to screening; 14. Have participated in any clinical investigator within 3 months prior to screening; 15. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial; 16. Not suitable for this study as judged by the investigator. * For COPD patients, in addition to meeting the above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | From the enrollment of the subjects to 72 hours after the last administration | The Incidence of adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | from 0 to 72 hours after administration | maximum plasma concentration |
| t1/2 | from 0 to 72 hours after administration | half-life |
| AUC | from 0 to 72 hours after administration | area under the concentration-time curve |
| CL/F | from 0 to 72 hours after administration | apparent clearance |
| Forced Expiratory Volume in the first second (FEV1) for patients with COPD | From 0 before first administration to 24 hours after last administration | Mean Change From Baseline in Peak FEV1, Mean Change From Baseline FEV1 to Morning Trough FEV1 |
| Vz/F | from 0 to 72 hours after administration | apparent volume of distribution |
Countries
China
Outcome results
None listed