Safety and food-effect testing of HSK55879 tablets in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I, single-center, randomized, double-blind, placebo-controlled protocol enrolls healthy adult volunteers to characterize the safety, tolerability, pharmacokinetics (PK), and the effect of food on HSK55879 tablets. Participants are randomized to receive HSK55879 or placebo with timed blood sampling to measure drug concentrations and PK parameters. Safety monitoring includes vital signs, laboratory tests, ECGs, and recording of adverse events, with eligibility limited by age, weight/BMI, and contraceptive requirements. Findings will guide dosing and administration decisions for later patient-focused trials.

Why it matters

Who can join: the full rules

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.

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Where it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Meixia Chen
• Email: chenmeixia@haisco.com
• Phone: 028-67258779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.