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

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country96 target enrollmentDecember 25, 2023

ConditionsHealthy

InterventionsHSK39297

DrugsHSK39297

Overview

Phase: Phase 1
Intervention: HSK39297
Conditions: Healthy
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 96
Locations: 1
Primary Endpoint: The number and severity of treatment emergent adverse events (TEAEs) .
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 25, 2023

End Date

September 29, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
•18 years to 45 years (inclusive), male and female;
•Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-26 kg/m2 (inclusive) ;
•Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.

Exclusion Criteria

•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;
•Have an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;
•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.;
•Have a history of TB infection or are currently infected with TB;
•Have a history of any malignant tumors;
•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;
•Subjects whose results of routine 12-lead electrocardiograms were inconsistent with normal heart conduction and function;
•Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
•Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study;
•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;