A Phase I Study of XH-S002 in Healthy Volunteers | NCT06204419

NCT06204419

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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）

Name	Type	Description	Arm Group Labels	Other Names
XH-S002 （A）	Drug	XH-S002 powder will be administered orally as per assigned treatment regimen.	A (XH-S002)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.