A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HS… (NCT07521345) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
China46 participantsStarted 2026-03-20
Plain-language 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
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Healthy subjects aged 18 to 45 years (inclusive) at screening, male or female;
✓. 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);
✓. 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
✕. 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;
What they're measuring
1
The number and severity of treatment emergent adverse events (TEAEs)