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A Phase 1 Study of XH-S003 in Healthy Volunteers

NCT05946876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

  • Healthy

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

Sponsors & Collaborators

  • S-INFINITY Pharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946876 on ClinicalTrials.gov