Aspire announces IRB approval for in-human trial of aspirin formulation

Aspire Biopharma (ASBP) has received Institutional Review Board approval of the clinical trial protocol for its upcoming Phase I single-center clinical trial in the United States designed to evaluate safety, pharmacokinetics and pharmacodynamics, of its lead therapeutic candidate, an oral transmucosal fast-acting high-dose aspirin formulation. One clinical trial site has been activated with patient enrollment expected to total six to eight participants and the trials are expected to begin this week. The objectives of this Phase 1 single dose clinical study are to evaluate the safety, pharmacokinetics and pharmacodynamics of Aspire’s sublingual aspirin powder when administered orally in healthy adult volunteers. The Phase 1 clinical trial, which is being conducted in the United States, will compare the pharmacokinetic and pharmacodynamic characteristics of normal healthy adult volunteers administered a sublingual dose of 162.5 mg aspirin powder with control healthy subjects given 162.5 mg oral aspirin. The primary outcome measure will be plasma acetylsalicylic acid concentration versus time data.