A Phase I Study of XH-S004 in Healthy Volunteers

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: XH-S004 tablet; Drug: XH-S004 placebo tablet

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Luhe Hospital, Capital Medical University
      • Contact: Xuhong Wang, M.M.; Phone Number: 010-69543901-8408; Email: wangxuhong72@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XH-S004; 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 tablets will be administered orally as per assigned treatment regimen on schedualed days.
Placebo Comparator: XH-S004 placebo tablet; Participants will receive matching placebo as per assigned treatment regimen on scheduled days.	Drug: XH-S004 placebo tablet; XH-S004 placebo tablet (matched) will be administered orally as per assigned treatment regimen on schedualed days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: S-Infinity Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: XH-S004-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No