Recruiting NCT07521345
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK55879, Placebo.
- Who it may be relevant to
- Registry conditions: Healhty. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug HSK55879
Dose 1 to dose 5 - Drug Placebo
dose 1 to dose 5
Primary outcome measures
- The number and severity of treatment emergent adverse events (TEAEs) [Time frame: 15 days after single dose]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Anhui Medical University — Hefei
Identifiers
NCT: NCT07521345 · HSK55879-101