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A Phase I Study of XH-S004 in Healthy Volunteers

NCT06236841 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-05

No results posted yet for this study

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.

Conditions

  • Healthy Adults

Interventions

DRUG

XH-S004 tablet

XH-S004 tablets will be administered orally as per assigned treatment regimen on schedualed days.

DRUG

XH-S004 placebo tablet

XH-S004 placebo tablet (matched) will be administered orally as per assigned treatment regimen on schedualed days.

Sponsors & Collaborators

  • S-INFINITY Pharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • China

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 NCT06236841 on ClinicalTrials.gov