A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK44459 in Healthy Subjects

NCT ID: NCT06858657

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-17
• Study Completion Date: 2024-12-20

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 HSK44459 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: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HSK4449

Single or multiple oral doses of HSK44459, and food effect of HSK44459

Group Type: EXPERIMENTAL

HSK44459

Intervention Type: DRUG

Dose 1 to Dose 5

Placebo

Single or multiple oral doses of placebo, and food effect of placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

dose 1 to dose 5

Interventions

HSK44459

Dose 1 to Dose 5

Intervention Type: DRUG

placebo

dose 1 to dose 5

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 55 years (inclusive), male and female;

3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 19-26 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 history of any malignant tumors;

4. 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;

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

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

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

8. 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, or positive urine drug screen at screening;

9. Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice;

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

11. Subjects who have a allergic to any component of HSK44459 or allergic history to opiates;

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: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanjing Drum Tower Hospital

Nanjing, , China

Countries

China

Other Identifiers

HSK44459-101

Identifier Type: -

Identifier Source: org_study_id