drugset / Trial / NCT06119659

Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001

NCT06119659 ↗

Phase 0 Unknown 9 enrolled Zhejiang University
NaSingle-groupOpen-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
2023-11-20
Primary completion
2024-06-30
Completion
2025-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject KL001 Unknown 2.5e+12 vg/kg —
Subject KL001 Unknown 5e+12 vg/kg —
Subject KL001 Unknown 1e+13 vg/kg —

Indications