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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

April 8, 2025

Primary Completion Date

October 15, 2026

Study Completion Date

December 15, 2026

Conditions
Amyotrophic Lateral SclerosisALS
Interventions
DRUG

PLL001 or placebo daily subcutaneous injections

PLL001 consists of the combination of 4 drug substances (DS) each being a linear poly-lysine flexible backbone with an average length of 70 L-lysines linked with 10% of conjugated side chains all being small chain fatty acids (SCFAs) (acetate, butyrate, lactate and propionate). The remaining 90% of the lysine residues are present as bromide salt. PLL001 DP is presented as 20 mL vials containing 16 mL of a sterilised solution for SC injection with the following formula (5× concentration)

Trial Locations (10)

NSW 2170

RECRUITING

Liverpool Hospital, Liverpool

NSW 2031

RECRUITING

Neuroscience Research Australia, Sydney

QLD 4575

RECRUITING

Sunshine Coast University Hospital, Birtinya

QLD 4066

RECRUITING

Wesley Research Institute, Brisbane

QLD 4215

RECRUITING

Gold Coast University Hospital, Southport

SA 5042

RECRUITING

Flinders Medical Centre, Adelaide

VIC 3004

RECRUITING

Alfred Health, Melbourne

VIC 3162

RECRUITING

Calvary Health Care, Bethlehem, Melbourne

VIC 3168

RECRUITING

Monash Medical Centre, Neuroscience Research, Melbourne

WA 6009

RECRUITING

The Perron Institute for Neurological and Translational Science, Perth

All Listed Sponsors
lead

PLL TX AUSTRALIA PTY LTD

INDUSTRY