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Recruiting

NCT Number: NCT07521345

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

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

Recruiting

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location status: Recruiting

Location contact

Wei Hu

CONTACT

[email protected]

86-13856086475

qian zhang

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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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Treatment and study plan

HSK55879

Drug

Dose 1 to dose 5

Placebo

Drug

dose 1 to dose 5

Primary outcomes

  1. The number and severity of treatment emergent adverse events (TEAEs)

    Time frame: 15 days after single dose

    To assess the safety and tolerability of HSK55879 in healthy adult volunteers

Study contacts

Contact information is provided by the study sponsor or research team.

Meixia Chen

CONTACT

[email protected]

028-67258779

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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