Clinical trial NCT06204419: A Phase I Study of XH-S002 in Healthy Volunteers
Official title: A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of XH-S002 After Single Ascending Doses, Multiple Ascending Doses and Evaluation of Food Effects in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: S-INFINITY Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults.
timeFrame: Approximately 1～2weeks
measure: To access the safety and tolerability of multiple ascending dosed of XH-S002 in healthy adults.
timeFrame: Approximately 1～2weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References: