Healhty
Conditions
Brief summary
This is a single-center, random, double blind, placebo control clinical study to evaluate the safety, tolerability pharmacokinetics and food effect of HSK55879 in healthy subjects
Interventions
DRUGHSK55879
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to understand the nature, purpose, and requirements of the study, as well as the potential risks and adverse reactions, and have signed the written informed consent form prior to the start of the study; 2. Healthy subjects aged 18 to 45 years (inclusive) at screening, male or female; 3. Body weight ≥50 kg for male subjects and ≥45 kg for female subjects at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg/m² (inclusive); 4. Subjects (including their partners) agree to have no pregnancy plan from 14 days before screening until 3 months after the last dose, and agree to use reliable contraceptive measures during this period.
Exclusion criteria
1. Any history of disease that, in the investigator's judgment, may affect the safety evaluation of the subject or the in vivo disposition of the study drug, 2. Physical examination, vital signs, laboratory tests，abdominal ultrasound, or chest X-ray findings that are judged by the study physician to be clinically significant abnormalities; 3. Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion; 4. abnormal HbA1c at screening; 5. Abnormal liver function test results 6. Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \<90 mL/min/1.73 m² at screening; 7. Routine 12-lead electrocardiogram (ECG) findings that are not consistent with normal cardiac conduction and function. 8. History of gastrointestinal diseases, with current symptoms of digestive discomfort ; 9. Current or past history of drug abuse, or a positive urine drug screen at screening; 10. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening; 11. Pregnant or breastfeeding females; 12. Subjects who, in the investigator's opinion, have poor compliance or any other factor that makes them unsuitable for participation in this study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | 15 days after single dose | To assess the safety and tolerability of HSK55879 in healthy adult volunteers |
Countries
China
Contacts
CONTACTMeixia Chen
Outcome results
None listed