InhaleRx has recruited and dosed the first eight participants in a phase one clinical trial investigating the safety and pharmacokinetics (PK) of its novel inhaled cannabinoid formulation IRX211 targeting symptoms of breakthrough or acute pain.
A total of four cohorts of eight will receive either IRX211 or a placebo in a double-blind, randomised, placebo-controlled, single ascending dose study. Screening is already underway for the second cohort.
The trial is designed to assess the PK, safety and tolerability of single escalating doses of the drug in healthy subjects.
The results will guide phase 2 and subsequent trials as well as the firm’s regulatory strategy including submission to the US Food and Drug Administration for a New Drug Approval.
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.”