NCT06267183 A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
| NCT ID | NCT06267183 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai Synvida Biotechnology Co.,Ltd. |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2026-11-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form; 2. Subjects must have a Body Mass Index in the range of 19\~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg; 3. Subjects must be in good health as judged by the investigator. 4. Reliable contraception must be assured during and for some time after the trial. Exclusion Criteria: 1. Subjects with a history of drug or other substance anaphylaxis; 2. Subjects with respiratory symptoms or abnormal respiratory tract; 3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices; 4. Subjects with other diseases or factors with abnormal clinical manifestations; 5. Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result