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)

NCT05039099 ↗

Phase 2 Completed 73 enrolled AL-S Pharma
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

EvaluationDrugModalityDoseRoute
Subject AP-101 Unknown — Intravenous