PLL001
Are You Eligible?To evaluate the safety, tolerability, efficacy and pharmacodynamics of an investigational drug, PLL001 in adults with Amytrophic Lateral Sclerosis (ALS).
Research Objectives
Status
Recruitment
Total participants required
Study location
Study type
Patient group
About this clinical trial
ALS is a nervous system disease characterised by progressive muscle weakness and loss of bulk, speech and swallowing difficulty, loss of ability to perform daily functions independently, ultimately leading to paralysis and death. The purpose of this study is to assess the ability of PLL001 to help treat people with ALS and evaluate its safety for use. The investigational drug will be delivered by a short needle used to inject PLL001 or Placebo into the tissue layer between the skin and muscle known via a subcutaneous injection. Part 1 of the study is a single dose study where you will receive a single dose (PLL001 or placebo). Part 2 of the study is a multiple dose expansion study where you will receive a dose daily for 24 weeks (PLL001 or placebo). Part 3 is the Open Label Extension study where you will receive 10 doses of PLL001 over 26 weeks.
Trial information – https://www.clinicaltrials.gov/study/NCT06513546?cond=PLL001&rank=1
Eligibility
- Adults aged 18 and over
- Diagnosed with ALS within the past year
- If currently taking ALS medication, must have been on it for at least 4 weeks prior to study
Lead investigators
- A/Prof Robert Henderson
- Dr Po Sheng Yang
Clinical trial coordinator
- Jacqui Langton
Technical title
A Multi-centre, Phase 1/2, Randomised, Double-blind, Placebo-controlled Study with an Optional Open-label Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics of PLL001 for the Treatment of Subjects with Amyotrophic Lateral Sclerosis
Register your interest
If you would like more information about this clinical trial, please complete the contact form below.