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

Study Overview

• Status: Recruiting
• Conditions: Healhty
• Intervention / Treatment: Drug: HSK55879; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Meixia Chen; Phone Number: 028-67258779; Email: chenmeixia@haisco.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The Second Affiliated Hospital of Anhui Medical University
      • Sub-Investigator: qian zhang
      • Contact: Wei Hu; Phone Number: 86-13856086475; Email: hwgcp@ayefy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSK55879; Single oral dose of HSK55879, and food effect of HSK55879	Drug: HSK55879; Dose 1 to dose 5
Placebo Comparator: placebo; Single oral dose of placebo, and food effect of placobo	Drug: Placebo; dose 1 to dose 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HSK55879-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No