A Phase I Study of XH-S004 in Healthy Volunteers

NCT06236841 | Not Yet Recruiting Phase 1

• 1 other identifier: XH-S004-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [Safety and Tolerability] of single ascending oral dose of XH-S004 in healthy adults.

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

  Approximately 1~2 weeks.

• To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [Safety and Tolerability] of multiple ascending oral dose of XH-S004 in healthy adults.

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

  Approximately 2 months.

Study Arms (2)

XH-S004

EXPERIMENTAL

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

Drug: XH-S004 tablet

XH-S004 placebo tablet

PLACEBO COMPARATOR

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

Drug: XH-S004 placebo tablet

Interventions

XH-S004 tablet DRUG

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

XH-S004

XH-S004 placebo tablet DRUG

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

XH-S004 placebo tablet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• S-INFINITY Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Beijing LuHe Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: January 26, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)