Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HSK39004 Dry Powder Inhalation

NCT ID: NCT06971198

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2025-05-06

Brief Summary

To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 dry powder inhalation in healthy subjects.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HSK39004

Group Type: EXPERIMENTAL

HSK39004

Intervention Type: DRUG

0.75\~4mg

Placebo

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.75\~4mg

Interventions

HSK39004

0.75\~4mg

Intervention Type: DRUG

Placebo

0.75\~4mg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

HSK39004-T1-101

Identifier Type: -

Identifier Source: org_study_id