drugset / Trial / NCT06513546

A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients

NCT06513546 ↗

Phase 1/2 Not yet recruiting 153 enrolled PLL TX AUSTRALIA PTY LTD
RandomizedParallel-groupQuadruple-blindTreatment

Summary

FIH, Phase 1/2, multi-centre, randomised, double-blind, placebo controlled study with an optional open-label dosing extension to assess the safety, tolerability, efficacy, and Pharmacodynamics (PD) of single or multiple (up to 48 weeks QD) subcutaneous (SC) doses of PLL001 compared to placebo in subjects diagnosed with ALS.

Timeline

Start
2026-04-08
Primary completion
2026-12-15
Completion
2027-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PLL001 Other / unclassified — Subcutaneous