A Phase I Study of XH-S002 in Healthy Volunteers

NCT06204419 | Unknown Phase 1

• 1 other identifier: XH-S002-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S002 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S002.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• To access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults.

  Safety and tolerability of single dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.

  Approximately 1～2weeks

• To access the safety and tolerability of multiple ascending dosed of XH-S002 in healthy adults.

  Safety and tolerability of multiple dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.

  Approximately 1～2weeks

Study Arms (2)

A (XH-S002)

EXPERIMENTAL

Participants will receive XH-S002 once or twice daily on scheduled days.

Drug: XH-S002 （A）

B (Placebo)

EXPERIMENTAL

Participants will receive matching placebo once or twice daily on scheduled days.

Other: Placebo（B）

Interventions

XH-S002 （A） DRUG

XH-S002 powder will be administered orally as per assigned treatment regimen.

A (XH-S002)

Placebo（B） OTHER

XH-S002 Placebo (matched) will be administered orally as per assigned treatment regimen.

B (Placebo)

Eligibility Criteria

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

You may qualify if:

• Male or Female healthy adult participants aged 18\~45 years (inclusive);
• Male body weight is no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 25.0 kg/m2 (both inclusive).
• Participants are in a good health and have no clinically significant abnormalities as per medical history, clinical symptoms, vital signs, physical examination, 12-lead ECG, chest X-ray, abdominal ultrasound and clinical laboratory tests (hematology, urinalysis, serum chemistry, coagulation function and fecal occult blood) results.
• After having a detailed understanding on the nature, significance, possible benefits, possible inconvenience and potential risks of this clinical trial, Participants would be able to take part in this clinical trial voluntarily, communicate well with investigator, abide by protocol procedures and sign written informed consent form (ICF).
• Participants promise no plan on fertility and donating sperm or ovum, and to take effective physical contraception (including female partner) from screening until one month after the end of the study.

You may not qualify if:

• Pregnant or lactating woman, or woman with a positive pregnancy test.
• Participants who are suspected or confirmed to be allergic to similar ingredient or 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 current disorder of cardiovascular, pulmonary, endocrine, renal, hepatic, gastrointestinal, dermatology, immunology, hematology, neurology and psychiatric.
• Participants with clinically significant acute infection or concurrent severe infection (e.g., intravenous or oral antibiotics, anti-fungal or anti-viral drugs, etc.) or participant who has not recovered from infection within 2 weeks prior to screening.
• Participants who had a history of gastroesophageal reflux, dyspepsia, chronic nausea, or chronic diarrhea (≥3 stools per day, ≥4 weeks) within 6 months before screening.

Sponsors & Collaborators

• S-INFINITY Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Beijing Friendship Hospital, Capital Medical University

CONTACT

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: December 18, 2023
• First Posted: January 12, 2024
• Study Start: December 26, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)