NCT07469085 A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.
| NCT ID | NCT07469085 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Synvida Biotechnology Co.,Ltd. |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-04 |
| Primary Completion | 2026-10-31 |
Trial Parameters
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Brief Summary
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
Eligibility Criteria
Inclusion Criteria: 1. Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg/m², 18.5 ≤ Caucasian participants ≤ 32 kg/m²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg; 2. Healthy status: No evidence of active or chronic diseases in participants; 3. Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements. Exclusion Criteria: 1. Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases; 2. Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study; 3. Subjects with designated examination results reaching a specified value; 4. Subjects with abnormal laboratory test results deemed clinically significant by the investigator; 5. Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibo