Healthy Adults
Conditions
Brief summary
This is a phase I, randomised, double-blind placebo-controlled, 3-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of XH-S004 in healthy volunteers.
Interventions
XH-S004 tablets will be administered orally as per assigned treatment regimen on schedualed days
Matching placebo tablets will be administered orally as per assigned treatment regimen on schedualed days
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusive criteria: 1. Healthy male and female subjects, 18 to 45 years of age (inclusive) at Screening. 2. Male body weight no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 26.0 kg/m2 (both inclusive). 3. Medically healthy without no clinically significant abnormalities on the basis of inquiry, vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests (hematology, serum chemistry, coagulation function and urinalysis, etc,) , and chest X-ray, etc,. 4. Participants must be able to understand the procedures and methods of this study, and voluntarily take part in this study, and communicate well with investigators, and comply with requirements throughout the study, and sign the informed consent form (ICF). 5. Subjects must guarantee and agree to take effective contraceptive methods (example, condom and intrauterine device) other than oral medication from 14 days prior to signing ICF to 30 days after last dose, and have no plan to donate sperm and ovum during the study. Exclusive criteria: 1. Pregnant or lactating woman, or woman with a positive pregnancy test. 2. Participants who are suspected or confirmed to be allergic to any ingredients of investigational product, or participants who are allergic, or have a drug allergy history or specific allergic disorders (asthma, urticaria, eczema, etc.). 3. Participants with a medical history or a presence of significant cardiovascular, pulmonary, endocrine, urinary/reproductive, gastrointestinal, dermatologic, immunologic, hematological, neurological, psychiatric and infectious diseases or abnormalities; Or any acute, chronic disease or physiological condition that could interfere with the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To access the safety and tolerability of single ascending oral dose of XH-S004 in healthy adults. | Approximately 1~2 weeks. | The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests. |
| To access the safety and tolerability of multiple ascending oral dose of XH-S004 in healthy adults. | Approximately 2 months. | The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests. |
Countries
China