drugset / Trial / NCT06493279
Evaluate the Safety and Efficacy of Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis
Phase 1
Active not recruiting
9 enrolled
RJK Biopharma Ltd
Peking University Third Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of the study aims to evaluate the safety and tolerability of a single intrathecal injection of RJK002 in subjects with amyotrophic lateral sclerosis (ALS), and to determine the recommended Phase II dose (RP2D).
Timeline
- Start
- 2024-09-24
- Primary completion
- 2026-11-30
- Completion
- 2030-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RJK002 | Unknown | 3e+13 vg | Intrathecal |
| Subject | RJK002 | Unknown | 6e+13 vg | Intrathecal |
| Subject | RJK002 | Unknown | 1.2e+14 vg | Intrathecal |
| Subject | RJK002 | Unknown | 2.4e+14 vg | Intrathecal |