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Completed

NCT Number: NCT06236841

A Phase I Study of XH-S004 in Healthy Volunteers

This is a phase I, randomised, double-blind placebo-controlled, 3-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of XH-S004 in healthy volunteers.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing LuHe Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusive criteria:

  • Healthy male and female subjects, 18 to 45 years of age (inclusive) at Screening.
  • Male body weight no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 26.0 kg/m2 (both inclusive).
  • Medically healthy without no clinically significant abnormalities on the basis of inquiry, vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests (hematology, serum chemistry, coagulation function and urinalysis, etc,) , and chest X-ray, etc,.
  • Participants must be able to understand the procedures and methods of this study, and voluntarily take part in this study, and communicate well with investigators, and comply with requirements throughout the study, and sign the informed consent form (ICF).
  • Subjects must guarantee and agree to take effective contraceptive methods (example, condom and intrauterine device) other than oral medication from 14 days prior to signing ICF to 30 days after last dose, and have no plan to donate sperm and ovum during the study.

Exclusive criteria:

  • Pregnant or lactating woman, or woman with a positive pregnancy test.
  • Participants who are suspected or confirmed to be allergic to any ingredients of investigational product, or participants who are allergic, or have a drug allergy history or specific allergic disorders (asthma, urticaria, eczema, etc.).
  • Participants with a medical history or a presence of significant cardiovascular, pulmonary, endocrine, urinary/reproductive, gastrointestinal, dermatologic, immunologic, hematological, neurological, psychiatric and infectious diseases or abnormalities; Or any acute, chronic disease or physiological condition that could interfere with the study results.

Treatment and study plan

XH-S004 tablet

Other

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

Other names: FXS7553

Placebo tablet

Other

Matching placebo tablets will be administered orally as per assigned treatment regimen on schedualed days

Primary outcomes

  1. To access the safety and tolerability of single ascending oral dose of XH-S004 in healthy adults.

    Time frame: Approximately 1~2 weeks.

    The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests.

  2. To access the safety and tolerability of multiple ascending oral dose of XH-S004 in healthy adults.

    Time frame: Approximately 2 months.

    The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests.

Sponsors and collaborators

Lead sponsor

S-INFINITY Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of XH-S004 After Single Ascending Doses, Multiple Ascending Doses and Evaluation of Food Effects in Healthy Volunteers

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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