A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects

NCT ID: NCT06350279

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-25
• Study Completion Date: 2024-09-29

Brief Summary

This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

HSK39297

Single or multiple oral doses of HSK39297

Group Type: EXPERIMENTAL

HSK39297

Intervention Type: DRUG

50-600mg

Placebo

Placebo

Group Type: EXPERIMENTAL

HSK39297

Intervention Type: DRUG

50-600mg

Interventions

HSK39297

50-600mg

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. Bodymass index (BMI) : 18-26 kg/m2 (inclusive) ;

4. 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 an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;

3. Have a clear history of capsular bacteria infection within 6 months before screening, inncluding but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae B, etc.;

4. Have a history of TB infection or are currently infected with TB;

5. Have a history of any malignant tumors;

6. The abnormalities were clinically significant during the screening period, such as physical examination, vital signs, blood biochemistry, blood routine, coagulation, urine routine, blood pregnancy test, infectious diseases and X-ray;

7. Subjects whose results of routine 12-lead electrocardiograms were inconsistent with normal heart conduction and function;

8. Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;

9. Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study;

10. 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;

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

12. 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;

13. Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;

14. Subjects who have a allergic to any component of HSK30297 or allergic history to opiates;

15. Any drug that inhibits or induces drug metabolism enzymes or P-gp inhibitor have been administered within 28 days prior to initial administration of the investigational drug;

16. Subjects who use any live vaccine within 30 days prior to screening;

17. Have participated in any clinical investigator within 3 months prior to screening;

18. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;

19. 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

Beijing Tongren Hospital

Beijing, , China

Countries

China

Other Identifiers

HSK39297-101

Identifier Type: -

Identifier Source: org_study_id