drugset / Trial / NCT07256301
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
RandomizedSequentialOpen-labelTreatment
Summary
This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Timeline
- Start
- 2024-01-03
- Primary completion
- 2026-08-31
- Completion
- 2026-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EA5 | Monoclonal antibody | 900 mg | Intravenous |
| Subject | EA5 | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | EA5 | Monoclonal antibody | 1400 mg | Intravenous |