InhaleRx has enrolled and administered doses to the first eight participants in a phase one clinical trial examining the safety and pharmacokinetics (PK) of its inhaled cannabinoid treatment IRX211, which targets breakthrough and acute pain symptoms.
The study will enrol four cohorts of eight participants in total, each receiving either IRX211 or a placebo as part of a double-blind, randomised, placebo-controlled, single ascending dose design. Screening for the second cohort is already in progress.
The trial's primary aim is to evaluate the PK, safety, and tolerability of single escalating doses of the drug in healthy volunteers.
Findings from the trial will shape the direction of phase 2 and later studies, as well as the company's regulatory pathway, including a planned New Drug Approval submission to the US Food and Drug Administration.
CEO Darryl Davies said: "InhaleRx has closed out the first of four cohorts ahead of schedule which is a significant milestone for the company.
"We are tracking really well with screening our next cohort and we look forward to evaluating the safety, tolerability, and pharmacokinetic profiles of IRX211 to inform our phase 2."
