1. Nasal administration of the neuroprotective candidate NeuroEPO to healthy volunteers: a randomized, parallel, open-label safety study
- Author
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Orestes Santos-Morales, Alina Díaz-Machado, Daise Jiménez-Rodríguez, Yaisel Pomares-Iturralde, Tatiana Festary-Casanovas, Carlos A. González-Delgado, Sonia Pérez-Rodríguez, Eulalia Alfonso-Muñoz, Carmen Viada-González, Patricia Piedra-Sierra, Idrian García-García, Daniel Amaro-González, for the NeuroEPO Study Group, Julio César García-Rodríguez, Iliana Sosa-Testé, Alicia Lagarto-Parra, Laura Barrero-Viera, Marlene David-Baldo, Maura Tamayo-Rodríguez, Ivonne Rivero-Vázquez, Gricel González-Gamiz, Alis Martín-Trujillo, Yasmila Rodríguez-Fernández, Ana Alfa Ledo-de la Luz, Maylén Álvarez-Delgado, Ivón Howland-Álvarez, and Yolanda Cruz-Gómez
- Subjects
Non-hematopoietic recombinant erythropoietin ,NeuroEPO ,Stroke ,Neurodegenerative diseases ,Healthy volunteers ,Safety ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Abstract Background Delivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models. In the current study, the safety of NeuroEPO was evaluated for the first time in humans. Methods A phase I, randomized, parallel, open-label study was carried out in healthy volunteers. They received, intranasally, 1 mg of NeuroEPO every 8 h during 4 days (Group A) or 0.5 mg of NeuroEPO (Group B) with the same schedule. The working hypothesis was that intranasal NeuroEPO produce
- Published
- 2017
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