drugset / Trial / NCT07051629
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SIF001, a monoclonal antibody with the potential to treat epilespy
Timeline
- Start
- 2025-06-16
- Primary completion
- 2027-01-15
- Completion
- 2027-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIF001 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | SIF001 | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | SIF001 | Monoclonal antibody | 50 mg/kg | Intravenous |
| Subject | SIF001 | Monoclonal antibody | 80 mg/kg | Intravenous |