Prana Biotechnology has received approval from the ethics committee to begin a Phase I clinical trial to investigate the safety, tolerability and pharmacokinetics of PBT434 for the treatment of Parkinsonian diseases.
The company has already started enrolling the first cohort of healthy subjects for the trial.
Healthy adult volunteers between the ages of 18-55, and healthy elderly subjects older than 65 will be enrolled in the trial.
The Phase I trial comprises two parts, both of which are randomised, double-blind, and placebo-controlled.
As part of the trial, up to six single-dose cohorts and four repeated-dose cohorts will be examined.
Subjects in the single-ascending dose (SAD) portion of the trial will receive one single oral dose of PBT434 and will be observed for 72 hours for the drug’s safety and blood levels.
In the repeated dose portion, subjects will be given eight days dosing with PBT434 with safety and testing for drug disposition over the same duration.
The trial’s primary goal includes the evaluation of safety and tolerability of PBT434 after single and multiple oral dose administration.
Its secondary endpoints feature various pharmacokinetics measures to understand how PBT434 is absorbed and metabolised in the body.
The single-centre study is currently being conducted at Nucleus Network in Melbourne, Australia.
Prana Biotechnology Clinical Development senior vice-president and chief medical officer Dr David Stamler said: “Following successful completion of this study, we aim to evaluate PBT434 in Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP), which are devastating neurodegenerative diseases with no approved therapies.”
Prana’s lead drug candidate PBT434 is a new generation of small molecules designed to inhibit the aggregation of alpha(α)-synuclein and tau, which are vital intracellular proteins that are implicated in neurodegenerative diseases, including Parkinson’s disease and atypical parkinsonism.
