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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK55879 | Experimental | Single oral dose of HSK55879, and food effect of HSK55879 |
|
| placebo | Placebo Comparator | Single oral dose of placebo, and food effect of placobo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK55879 | Drug | Dose 1 to dose 5 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | To assess the safety and tolerability of HSK55879 in healthy adult volunteers | 15 days after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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,
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;
Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion;
abnormal HbA1c at screening;
Abnormal liver function test results
Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation <90 mL/min/1.73 m² at screening;
Routine 12-lead electrocardiogram (ECG) findings that are not consistent with normal cardiac conduction and function.
History of gastrointestinal diseases, with current symptoms of digestive discomfort ;
Current or past history of drug abuse, or a positive urine drug screen at screening;
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;
Pregnant or breastfeeding females;
Subjects who, in the investigator's opinion, have poor compliance or any other factor that makes them unsuitable for participation in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meixia Chen | Contact | 028-67258779 | chenmeixia@haisco.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
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| Drug |
dose 1 to dose 5 |
|