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

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.

This will test whether HSK55879 tablets are safe, well tolerated, and how food affects their absorption in healthy adults aged 18–45.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (industry)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07521345 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy men and women aged 18–45 with BMI 19.0–28.0 (≥50 kg for men, ≥45 kg for women), able to give informed consent and agree to required contraception, are the intended participants.

Not a fit: People with active medical conditions, those outside the specified age or BMI/weight limits, pregnant individuals or those unwilling to use contraception, or those who cannot attend the study site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could define a safe dosing range and whether food alters absorption, enabling informed dosing in future patient trials.

How similar studies have performed: Food-effect and first-in-human Phase I PK studies are a standard and generally successful step in drug development, although HSK55879 itself appears novel with no prior public clinical data.

Eligibility criteria

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.

    \-

Where this trial is running

Hefei, Anhui

• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Meixia Chen

Conditions: Healhty