Status:
COMPLETED
Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HSK39004 Dry Powder Inhalation
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 dry powder inhalation in healthy subjects.
Eligibility Criteria
Inclusion
- Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
- 18 years to 45 years (inclusive), male and female;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-26 kg/m2 (inclusive) ;
- Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values;
- Never smoked or have quit smoking for ≥ 12 months and have a previous smoking history of \< 5 pack per years;
- Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
Exclusion
- 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;
- Have a history of any malignant tumors;
- Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
- Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
- Acute respiratory infections occurred within 6 weeks before screening and/or before randomization;
- Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage within 48 hours before the administration;
- 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;
- Have a history of drug abuse prior to screening, or positive urine drug screen at screening;
- Blood donation (or blood loss) ≥400 mL within 3 months prior to the screening;
- Subjects who have a allergic to any component of HSK39004 or allergic history;
- Subjects who use any live vaccine within 30 days prior to screening;
- Have participated in any clinical investigator within 3 months prior to screening;
- A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
- Not suitable for this study as judged by the investigator.
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06971198
Start Date
February 10 2025
End Date
May 6 2025
Last Update
May 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China