Healthy Volunteers
Conditions
Brief summary
To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 dry powder inhalation in healthy subjects.
Interventions
DRUGHSK39004
0.75\ 4mg
DRUGPlacebo
0.75\ 4mg
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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. Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values; 5. Never smoked or have quit smoking for ≥ 12 months and have a previous smoking history of \< 5 pack per years; 6. Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
Exclusion criteria
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; 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 within 48 hours before the administration; 7. 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; 8. Have a history of drug abuse prior to screening, or positive urine drug screen at screening; 9. Blood donation (or blood loss) ≥400 mL within 3 months prior to the screening; 10. Subjects who have a allergic to any component of HSK39004 or allergic history; 11. Subjects who use any live vaccine within 30 days prior to screening; 12. Have participated in any clinical investigator within 3 months prior to screening; 13. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial; 14. Not suitable for this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events | From the enrollment of the subjects to 72 hours after the last administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC | from 0 to 72 hours after administration | area under the concentration-time curve |
| Cmax | from 0 to 72 hours after administration | maximum plasma concentration |
| t1/2 | from 0 to 72 hours after administration | half-life |
| Vz/F | from 0 to 72 hours after administration | apparent volume of distribution |
| CL/F | from 0 to 72 hours after administration | apparent clearance |
Countries
China
Outcome results
None listed