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

Healthy Clinical Trial

Official title:

A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350279
• Other study ID #: HSK39297-101
• Status: Recruiting
• Phase: Phase 1
• Start date: December 25, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: Meixia Chen, PhD
• Phone: 028-67258779
• Email: chenmeixia[@]haisco.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HSK39297
50-600mg

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and severity of treatment emergent adverse events (TEAEs) .	To assess the safety and tolerability of single or multiple oral dose of HSK39297 in healthy adult volunteers	9 days after single dose and 16 days after the first dose of multiple doses
Secondary	AUC	Area under the plasma concentration versus time curve (AUC) on Day 1 and D10	Pre-dose to 168 hours post-dose
Secondary	Cmax	The maximun plasma concentration of HSK39297	Pre-dose to 168 hours post-dose
Secondary	Tmax	Time of maximum concentration of HSK39297	Pre-dose to 168 hours post-dose
Secondary	t1/2	half-life	Pre-dose to 168 hours post-dose
Secondary	AP change	change from baselin of the alternative pathway activity	Pre-dose to 168 hours post-dose
Secondary	Bb	change from baselin of the concentration of Bb	Pre-dose to 168 hours post-dose