Argenica Therapeutics Limited’s (ASX: AGN) ethics application to Bellberry’s Human Research Ethics Committee (HREC) to commence a Phase 1 healthy participant study of ARG-007 has been approved.
Argenica is a biotechnology company developing novel therapeutics to reduce brain tissue death after stroke.
The trial will be run by Linear Clinical Research (Linear) at its dedicated clinical trial facility in Perth, Western Australia.
Linear will now commence the process of recruiting healthy volunteers into the trial. Dosing of the first cohort of volunteers is expected to commence in October.
We are delighted to receive ethics approval for our first-in-human study of ARG-007. This is a pivotal moment for Argenica, as we take ground-breaking research from the Perron Institute and the University of Western Australia into the clinic,” CEO and Managing Director, Dr Liz Dallimore, said.
“We look forward to working with Linear on this trial and will provide regular updates as we progress through each cohort.”
Clinical Trial Design
Up to 32 subjects will be dosed in the Phase 1 trial to be conducted at the Linear Clinical Research trial facility in Perth, Western Australia. Subjects will be randomly assigned to receive either ARG-007 or matching placebo (ratio 3:1 respectively) administered as a single IV dose on Day 1.
Both the site staff treating subjects and the subjects themselves will be blinded to the treatments being administered.
There will be four cohorts investigated in the study, with eight participants in each cohort. Subjects will be enrolled into sequential cohorts with the first cohort receiving either the lowest dose of ARG-007 or a placebo.
Following this, the next cohort will receive a slightly higher dose (or placebo), then so on. Each cohort will include two sentinel subjects (one assigned to ARG-007 and 1 assigned to placebo).
The two sentinel subjects will be dosed 24 hours prior to the remaining subjects in the cohort and monitored for 24 hours.
Should the dose be deemed to be safe and well tolerated after 24 hours by the investigator, the remaining six subjects in the cohort will be dosed.
Following dosing, safety, tolerability, PK, and immune response assessments will be performed for all participants in the cohort. Safety data will be reviewed by a Scientific Review Committee prior to dose escalation to the next dose ascending cohort.
