A Phase I Study of XH-S004 in Healthy Volunteers

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236841
• Other study ID #: XH-S004-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 26, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: S-Infinity Pharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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

Locations

Country	Name	City	State
China	Beijing LuHe Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
S-Infinity Pharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.