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

NCT07521345 | Recruiting Phase 1

• 1 other identifier: HSK55879-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healhty

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HSK55879

EXPERIMENTAL

Single oral dose of HSK55879, and food effect of HSK55879

Drug: HSK55879

placebo

PLACEBO COMPARATOR

Single oral dose of placebo, and food effect of placobo

Drug: Placebo

Interventions

HSK55879 DRUG

Dose 1 to dose 5

HSK55879

Placebo DRUG

dose 1 to dose 5

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Central Study Contacts

Meixia Chen

CONTACT

028-67258779; chenmeixia@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: March 20, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)