drugset / Trial / NCT05039099
A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
Timeline
- Start
- 2021-09-02
- Primary completion
- 2025-08-13
- Completion
- 2025-08-13
Outcome
Met primary endpoint
release “Phase 2 of AP-101 in sporadic ALS and mutant SOD1-ALS met its primary safety and tolerability endpoint” neurimmune.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AP-101 | Unknown | — | Intravenous |