Business
Aspire Biopharma Holdings, Inc., Announces Phase 1 Clinical Trial Initiation of its Oral Transmucosal Fast-Acting High-Dose Aspirin Formulation
One clinical trial site activated Patient enrollment expected in April Trial designed to evaluate safety, pharmacokinetics and pharmacodynamics, of Aspire's sublingual aspirin product Aspire anticipates releasing initial clinical data from trial at ...
About this update from Aspire Biopharma Holdings, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"One clinical trial site activated","length":33,"tagName":"p"}]},{"val":[{"type":"text","content":"Patient enrollment expected in April","length":36,"tagName":"p"}]},{"val":[{"type":"text","content":"Trial designed to evaluate safety, pharmacokinetics and pharmacodynamics, of Aspire's sublingual aspirin product","length":116,"tagName":"p"}]},{"val":[{"type":"text","content":"Aspire anticipates releasing initial clinical data from trial at the end of the second quarter","length":94,"tagName":"p"}]},{"val":[{"type":"text","content":"Aspire intends to request "fast track" approval on FDA application for its high-dose aspirin product","length":110,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":389,"olType":false},{"type":"text","content":"HUMACAO, PR AND NEW YORK, NY / ACCESS Newswire / April 9, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today announced initiation of its Phase 1 single- center clinical study of its lead therapeutic candidate, an oral transmucosal fast-acting high-dose aspirin formulation.","length":402,"tagName":"p"},{"type":"text","content":"One clinical trial site has been activated with patient enrollment expected to total six to eight participants and begin during April.","length":134,"tagName":"p"},{"type":"text","content":"Phase 1 Study DesignThe 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 (approximately two 81 mg aspirin tablets). The primary outcome measure will be plasma acetylsalicylic acid (ASA) concentration versus time data (pre-dose and up to 24 hours post dose.)","length":720,"tagName":"p"},{"type":"text","content":"This Phase 1 trial is expected to provide information required to select the optimal drug product formulation and inform the design of a secon...