Testing the safety and effects of XH-S002 in healthy adults

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

This study tests a new drug called XH-S002 in healthy adults to see if it's safe and how it works in the body, including how food affects it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: S-INFINITY Pharmaceuticals Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06204419 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of a new drug, XH-S002, in healthy volunteers. It involves administering single and multiple ascending doses of the drug to assess how it behaves in the body. Additionally, the study examines how food intake affects the drug's performance. Participants will be closely monitored for any adverse effects and overall health during the trial.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 45 years with a specific weight and BMI range.

Not a fit: Patients with significant health issues or those outside the specified age and weight criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of XH-S002's safety profile and its potential use in treating various conditions.

How similar studies have performed: While this approach is common in early-phase drug testing, the specific drug XH-S002 is novel and has not been tested in previous studies.

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.

Where this trial is running

Beijing, Beijing

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Beijing Friendship Hospital, Capital Medical University

Conditions Healthy Adults