A Phase I Study of XH-S004 in Healthy Volunteers
A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of XH-S004 After Single Ascending Doses, Multiple Ascending Doses and Evaluation of Food Effects in Healthy Volunteers
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China
- Beijing LuHe Hospital, Capital Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusive criteria:
- Healthy male and female subjects, 18 to 45 years of age (inclusive) at Screening.
- 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).
- 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,.
- 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).
- 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:
- Pregnant or lactating woman, or woman with a positive pregnancy test.
- 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.).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: XH-S004 tablet
Participants will receive XH-S004 as per assigned treatment regimen on scheduled days. Part 1 (single ascending dose, 8 cohorts, starting at 5 mg), Part 2 (multiple ascending dose, 3 cohorts), and Part 3 (food effect, 1 cohort), all administered as XH-S004 oral tablets |
XH-S004 tablets will be administered orally as per assigned treatment regimen on schedualed days
Other Names:
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Placebo Comparator: XH-S004 placebo tablet
Participants will receive matching placebo as per assigned treatment regimen on scheduled days. Part 1 (single ascending dose, 8 cohorts) and Part 2 (multiple ascending dose, 3 cohorts) , all administered as matching placebo to XH-S004. |
Matching placebo tablets will be administered orally as per assigned treatment regimen on schedualed days |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To access the safety and tolerability of single ascending oral dose of XH-S004 in healthy adults.
Time Frame: Approximately 1~2 weeks.
|
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests. |
Approximately 1~2 weeks.
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|
To access the safety and tolerability of multiple ascending oral dose of XH-S004 in healthy adults.
Time Frame: Approximately 2 months.
|
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests. |
Approximately 2 months.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XH-S004-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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