drugset / Trial / NCT05946876

A Phase 1 Study of XH-S003 in Healthy Volunteers

NCT05946876 ↗

Phase 1 Completed 77 enrolled S-INFINITY Pharmaceuticals Co., Ltd
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2023-08-24
Primary completion
2024-07-11
Completion
2024-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject XH-S003 Unknown 25 mg Oral
Subject XH-S003 Unknown 50 mg Oral
Subject XH-S003 Unknown 100 mg Oral
Subject XH-S003 Unknown 200 mg Oral
Subject XH-S003 Unknown 400 mg Oral

Indications

No indication recorded.