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COMPLETED
NCT05946876
PHASE1

A Phase 1 Study of XH-S003 in Healthy Volunteers

Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

77

Start Date

2023-08-24

Completion Date

2024-08-14

Last Updated

2026-09-25

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia