A Phase I Study of XH-S004 in Healthy Volunteers
Phase 1
Not yet recruiting
- Conditions
- Healthy Adults
- Interventions
- Drug: XH-S004 tabletDrug: XH-S004 placebo tablet
- Registration Number
- NCT06236841
- Lead Sponsor
- S-Infinity Pharmaceuticals Co., Ltd
- Brief Summary
This is a phase I, randomised, double-blind placebo-controlled, 3-part study to assess the safety, tolerability, pharmacokinetics and food effect of single and multiple oral doses of XH-S004 in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XH-S004 XH-S004 tablet Participants will receive XH-S004 as per assigned treatment regimen on scheduled days. Starting dose in single asceding dose: 5 mg. XH-S004 placebo tablet XH-S004 placebo tablet Participants will receive matching placebo as per assigned treatment regimen on scheduled days.
- Primary Outcome Measures
Name Time Method To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [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.
To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beijing LuHe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China