APRIL: A double-blind, placebo-controlled, randomized, Phase Ib/IIa clinical study of ApTOLL for the treatment of acute ischemic stroke

Autor: Macarena Hernández-Jiménez, Francisco Abad-Santos, Ian Cotgreave, Jaime Gallego, Bernd Jilma, Alan Flores, Tudor G. Jovin, José Vivancos, Carlos A. Molina, Joan Montaner, Joaquín Casariego, Mads Dalsgaard, María Hernández-Pérez, David S. Liebeskind, Erik Cobo, Marc Ribo
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Frontiers in Neurology, Vol 14 (2023)
Druh dokumentu: article
ISSN: 1664-2295
DOI: 10.3389/fneur.2023.1127585
Popis: 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
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