This notice of no objection allows for the initiation of human clinical studies in Canada. The first Phase I clinical trial will assess the safety of PMX-30063. The protocol for the study involves a dose-escalation study in healthy volunteers in which each subject will receive a single dose of PMX-30063. Upon successful completion of the first clinical study, PolyMedix plans to initiate a second clinical trial to mimic the expected clinical dosing regimen.
The second trial, also to be conducted in healthy volunteers, will involve repeat dosing of two intravenous infusions per day, for five to seven days. Following these clinical trials, additional clinical studies and regulatory submissions will be required to obtain regulatory approval from the FDA and other regulatory bodies before PMX-30063 could be commercially sold.