NCT05946876

A Phase 1 Study of XH-S003 in Healthy Volunteers

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics of XH-S003 After Single and Multiple Ascending Doses, Plus the Evaluation of Food Effects in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: S-INFINITY Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomised, first-in-human, double-blinded, placebo-controlled, SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) study to assess the PK, safety, and tolerability of XH-S003 in healthy volunteers. In addition, this study evaluates the effects of food on XH-S003 under a two-period, cross-over study setting.

Detailed description

The study is composed of three parts. Part A (SAD portion, 5 cohorts) and Part B (MAD portion, 3 cohorts) of the study will enrol eligible participants and provide various doses of XH-S003 or placebo at a ratio of 3:1 in each cohort. Part C of the study plans to evaluate the food effect on XH-S003.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	XH-S003 (A)	IP: XH-S003 IP: XH-S003 Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral
OTHER	Placebo (B)	Dose: 25 mg, 100 mg Dose Formulation: Capsule Route of Administration: Oral

Timeline

• Start date: 2023-08-24
• Primary completion: 2024-07-11
• Completion: 2024-08-14
• First posted: 2023-07-14
• Last updated: 2024-11-19

Locations

1 site across 1 country: Australia