A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Food Effects of XH-S004 Single and Multiple Ascending Doses in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- XH-S004 tablet
- Conditions
- Healthy Adults
- Sponsor
- S-Infinity Pharmaceuticals Co., Ltd
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
XH-S004
Participants will receive XH-S004 as per assigned treatment regimen on scheduled days. Starting dose in single asceding dose: 5 mg.
Intervention: XH-S004 tablet
XH-S004 placebo tablet
Participants will receive matching placebo as per assigned treatment regimen on scheduled days.
Intervention: XH-S004 placebo tablet
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Time Frame: Approximately 1~2 weeks.
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests.