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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06204419
Other study ID # XH-S002-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 26, 2023
Est. completion date October 2024

Study information

Verified date December 2023
Source S-Infinity Pharmaceuticals Co., Ltd
Contact Beijing Friendship Hospital, Capital Medical University
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 86
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Male or Female healthy adult participants aged 18~45 years (inclusive); 2. 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). 3. 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. 4. 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). 5. 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. Exclusion Criteria: 1. Pregnant or lactating woman, or woman with a positive pregnancy test. 2. 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.). 3. Participants with a medical history or a current disorder of cardiovascular, pulmonary, endocrine, renal, hepatic, gastrointestinal, dermatology, immunology, hematology, neurology and psychiatric. 4. 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. 5. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
XH-S002 (A)
XH-S002 powder will be administered orally as per assigned treatment regimen.
Other:
Placebo(B)
XH-S002 Placebo (matched) will be administered orally as per assigned treatment regimen.

Locations

Country Name City State
China Beijing Friendship 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 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
Primary 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
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