drugset / Trial / NCT06125756
Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001
NaSequentialOpen-labelTreatment
Summary
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels.
Timeline
- Start
- 2023-12-20
- Primary completion
- 2024-09-20
- Completion
- 2025-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KL001 | Unknown | 2.5e+12 vg/kg | — |
| Subject | KL001 | Unknown | 5e+12 vg/kg | — |
| Subject | KL001 | Unknown | 1e+13 vg/kg | — |