Clinical trial NCT06350279: A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
Official title: A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: HSK39297
healthy subjects
Phase I
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: The number and severity of treatment emergent adverse events (TEAEs) .
timeFrame: 9 days after single dose and 16 days after the first dose of multiple doses
Secondary outcomes:
measure: AUC
timeFrame: Pre-dose to 168 hours post-dose
measure: Cmax
timeFrame: Pre-dose to 168 hours post-dose
measure: Tmax
timeFrame: Pre-dose to 168 hours post-dose
measure: t1/2
timeFrame: Pre-dose to 168 hours post-dose
measure: AP change
timeFrame: Pre-dose to 168 hours post-dose
measure: Bb
timeFrame: Pre-dose to 168 hours post-dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References: