Argenica Therapeutics Limited announced that last week the first subjects in the second cohort of its Phase 1 clinical trial of ARG-007 were dosed. The subjects in the second cohort receive a higher dose of ARG-007 than the first cohort. Importantly, the dosed subjects in the sentinel group showed no serious safety issues or
adverse events 24 hours after dosing and therefore dosing of the remaining participants in cohort two will now be completed over the next few days. Following the dosing of these participants, all follow up data will be presented to the Safety Review Committee who will then confirm the progress of the trial to the next cohort.
The Phase 1 clinical trial, conducted at Linear Clinical Research facility in Perth, Western Australia, is designed to assess the safety and tolerability of ARG-007 across four cohorts of healthy adult volunteers, with each cohort receiving an ascending dose of ARG-007. The first volunteer dosed in each cohort is a sentinel subject, meaning this single volunteer receives the investigational drug at least 24 hours prior to the remaining subjects in the dose cohort. A second volunteer receives a placebo injection of saline at the same time as the sentinel subject. The intention of the sentinel is to identify any unpredicted serious safety issues
related to drug dosing in a single subject prior to exposing a larger group of subjects.