Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-04-09
46
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide written informed consent before starting
- Healthy males or females aged 18 to 45 years at screening
- Body weight at least 50 kg for males and 45 kg for females
- Body mass index (BMI) between 19.0 and 28.0 kg/m²
- Agree to avoid pregnancy and use reliable contraception from 14 days before screening until 3 months after last dose
You will not qualify if you...
- History of diseases affecting safety or drug processing as judged by the investigator
- Abnormal findings on physical exam, vital signs, lab tests, abdominal ultrasound, or chest X-ray
- Past or current gastrointestinal, liver, kidney, or other diseases affecting drug absorption or metabolism
- Abnormal HbA1c or liver function tests at screening
- Estimated glomerular filtration rate (eGFR) below 90 mL/min/1.73 m²
- Abnormal routine 12-lead ECG results
- Current digestive discomfort or history of gastrointestinal diseases
- History of drug abuse or positive urine drug screen
- Positive for hepatitis B, hepatitis C, syphilis, or HIV antibodies
- Pregnant or breastfeeding females
- Poor compliance or other factors making participation unsuitable according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
Research Team
M
Meixia Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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