A Phase I Study of XH-S004 in Healthy Volunteers

S-Infinity Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Adults

Treatments: Drug: XH-S004 placebo tablet; Drug: XH-S004 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06236841

XH-S004-101

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusive criteria:

1. Healthy male and female subjects, 18 to 45 years of age (inclusive) at Screening.
2. 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).
3. 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,.
4. 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).
5. 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:

1. Pregnant or lactating woman, or woman with a positive pregnancy test.
2. 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.).
3. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

XH-S004

Experimental group

Description:

Participants will receive XH-S004 as per assigned treatment regimen on scheduled days. Starting dose in single asceding dose: 5 mg.

Treatment:

Drug: XH-S004 tablet

XH-S004 placebo tablet

Placebo Comparator group

Description:

Participants will receive matching placebo as per assigned treatment regimen on scheduled days.

Treatment:

Drug: XH-S004 placebo tablet