Trials / Active Not Recruiting
Active Not RecruitingNCT06493279
Evaluate the Safety and Efficacy of Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis
A Single-arm, Open-label, Phase I Clinical Study to Evaluate the Safety and Efficacy of a Single Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis (ALS)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- Sponsor
- RJK Biopharma Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RJK002 Intrathecal injection | Eligible subjects will receive a single intrathecal administration of investigational product with dose 3E13vg (3ml), 6E13vg(6ml), and 1.2E14 vg(12ml) per person sequentially. |
Timeline
- Start date
- 2024-09-24
- Primary completion
- 2026-11-30
- Completion
- 2030-11-30
- First posted
- 2024-07-09
- Last updated
- 2025-11-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06493279. Inclusion in this directory is not an endorsement.