A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPLL TX AUSTRALIA PTY LTD
About this trial
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.
Eligibility criteria
Qualifiers
Males and females ≥18 years of age at the time of informed consent.
Diagnosed within the previous 1 year with laboratory-supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria.
Must have familial or sporadic ALS.
First ALS symptoms occurred no more than two (2) years prior to screening visit ALS disease duration from diagnosis no longer than 12 months at the Screening visit.
Disqualifiers
Has dementia or significant neurological, psychiatric, systemic, or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results.
Pregnant or nursing females.
History of drug/chemical/substance/alcohol abuse within the past 2 years prior to Screening, including cannabinoid therapies.
Significant symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration (at the discretion of the Investigator).
Trial design
Treatments tested in this trial
- PLL001 or placebo daily subcutaneous injections
Treatment groups
153 Participants
are divided into 3 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
PLL TX AUSTRALIA PTY LTD
Lead sponsor
Source ClinicalTrials.gov