2026-04-17T03:24:54Zhttps://recercat.cat/oai/request

oai:recercat.cat:2117/3863382026-01-30T08:38:48Zcom_2072_1033col_2072_452950

00925njm 22002777a 4500 dc Hernández Jiménez, Macarena author Abad Santos, Francisco author Cotgreave, Ian author Gallego, Jaime author Jilma, Bernd author Flores, Alan author Jovin, Tudor G. author Vivancos Mora, José author Molina, Carlos A. author Montaner, Joan author Casariego García, Joaquín author Cobo Valeri, Erik author 2023-02-24 In the reperfusion era, a new paradigm of treating patients with endovascular treatment (EVT) and neuroprotective drugs is emerging as a promising therapeutic option for patients with acute ischemic stroke (AIS). In this context, ApTOLL, a Toll-like receptor 4 (TLR4) antagonist with proven neuroprotective effect in preclinical models of stroke and a very good pharmacokinetic and safety profile in healthy volunteers, is a promising first-in-class aptamer with the potential to address this huge unmet need. This protocol establishes the clinical trial procedures to conduct a Phase Ib/IIa clinical study (APRIL) to assess ApTOLL tolerability, safety, pharmacokinetics, and biological effect in patients with AIS who are eligible for EVT. This will be a multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to evaluate the administration of ApTOLL together with EVT in patients with AIS. The study population will be composed of men and non-pregnant women with confirmed AIS with a <6h window from symptoms onset to ApTOLL/placebo administration. The trial is currently being conducted and is divided into two parts: Phase Ib and Phase IIa. In Phase Ib, 32 patients will be allocated to four dose ascending levels to select, based on safety criteria, the best two doses to be administered in the following Phase IIa in which 119 patients will be randomized to three arms of treatment (dose A, dose B, and placebo). Peer Reviewed Postprint (published version) Àrees temàtiques de la UPC::Matemàtiques i estadística::Matemàtica aplicada a les ciències Biomathematics Biomatemàtica Classificació AMS::92 Biology and other natural sciences::92B Mathematical biology in general APRIL: a double-blind, placebo-controlled, randomized, Phase Ib/IIa clinical study of ApTOLL for the treatment of acute ischemic stroke