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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: HSK39297

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Meixia Chen, PhD; Phone Number: 028-67258779; Email: chenmeixia@haisco.com
• Study Contact Backup: Name: Laichun Lu; Phone Number: 010-58268486

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tongren Hospital
    • Contact: Laichun Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Drug: HSK39297; 50-600mg
Experimental: HSK39297; Single or multiple oral doses of HSK39297	Drug: HSK39297; 50-600mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	Area under the plasma concentration versus time curve (AUC) on Day 1 and D10	Pre-dose to 168 hours post-dose
Cmax	The maximun plasma concentration of HSK39297	Pre-dose to 168 hours post-dose
Tmax	Time of maximum concentration of HSK39297	Pre-dose to 168 hours post-dose
t1/2	half-life	Pre-dose to 168 hours post-dose
AP change	change from baselin of the alternative pathway activity	Pre-dose to 168 hours post-dose
Bb	change from baselin of the concentration of Bb	Pre-dose to 168 hours post-dose

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Phase I; healthy subjects; HSK39297
• Other Study ID Numbers: HSK39297-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No