Healthy
Conditions
Keywords
HSK44459, healthy subjects, phase1
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.
Interventions
DRUGHSK44459
Dose 1 to Dose 5
DRUGplacebo
dose 1 to dose 5
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | 7 days after single dose and 3 days after the first dose of multiple doses | To assess the safety and tolerability of single or multiple oral dose of HSK44459 in healthy adult volunteers |
Countries
China
Outcome results
None listed