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

Last updated: May 13, 2025
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

HSK39004

Placebo

Clinical Study ID

NCT06971198
HSK39004-T1-101
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily sign the informed consent form, understand the trialprocedures, and bewilling 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 andforced 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 smokinghistory of < 5 pack per years;

  6. Subjects are willing to voluntarily use effectivecontraceptives from screening to atleast 3 months after the last dose administration.

Exclusion

Exclusion Criteria:

  1. Have a history of severe and uncontrolled diseases, such ascardiovascular,respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systemsdiseases 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 tointerfere with drug absorption, distribution, metabolism, or excretion;

  5. Acute respiratory infections occurred within 6 weeks before screening and/or beforerandomization;

  6. Have a history of high consumption of grapefruit juice, methylxanthinerich food orbeverage within 48 hours before the administration;

  7. Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) withinthe 3 months prior to screening;

  8. Have a history of drug abuse prior to screening, or positive urine drug screen atscreening;

  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 duringthe trial;

  14. Not suitable for this study as judged by the investigator.

Study Design

Total Participants: 26
Treatment Group(s): 2
Primary Treatment: HSK39004
Phase: 1
Study Start date:
February 10, 2025
Estimated Completion Date:
May 06, 2025

Connect with a study center

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong
    China

    Site Not Available

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