Aspire Biopharma Holdings Inc., headquartered in Humacao, Puerto Rico, has announced the dosing of the first patient in its Phase 1 clinical trial for an oral transmucosal fast-acting high-dose aspirin formulation. This trial is a single-center study conducted in the United States to evaluate the safety, pharmacokinetics, and pharmacodynamics of the company's lead therapeutic candidate. The trial involves healthy adult volunteers receiving a sublingual dose of 162.5 mg aspirin powder or granules, compared to control subjects given the same dose of oral aspirin. The primary outcome measure of the study will be plasma acetylsalicylic acid concentration over time. Aspire anticipates disclosing topline data from the trial early in the third quarter of 2025, which could potentially support accelerated approval, pending FDA review.
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