A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynami
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
| Condition(s) | Healthy Participants |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects. |
| Who can participate | 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 |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Shanghai Synvida Biotechnology Co.,Ltd. |
| Locations | Shanghai, China |
| Start date | 2026-04-04 |
| NCT ID | NCT07469085 |
| Official listing | https://clinicaltrials.gov/study/NCT07469085 |