Nasal administration of the neuroprotective candidate NeuroEPO to healthy volunteers: a randomized, parallel, open-label safety study

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. I...

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Bibliographic Details
Published in:BMC neurology 2017-07, Vol.17 (1), p.129-9, Article 129
Main Authors: Santos-Morales, Orestes, Díaz-Machado, Alina, Jiménez-Rodríguez, Daise, Pomares-Iturralde, Yaisel, Festary-Casanovas, Tatiana, González-Delgado, Carlos A, Pérez-Rodríguez, Sonia, Alfonso-Muñoz, Eulalia, Viada-González, Carmen, Piedra-Sierra, Patricia, García-García, Idrian, Amaro-González, Daniel, García-Rodríguez, Julio César, Sosa-Testé, Iliana, Lagarto-Parra, Alicia, Barrero-Viera, Laura, David-Baldo, Marlene, Tamayo-Rodríguez, Maura, Rivero-Vázquez, Ivonne, González-Gamiz, Gricel, Martín-Trujillo, Alis, Rodríguez-Fernández, Yasmila, Ledo-de la Luz, Ana Alfa, Álvarez-Delgado, Maylén, Howland-Álvarez, Ivón, Cruz-Gómez, Yolanda
Format: Article
Language:English
Subjects:
Administration, Intranasal
Adult
Alzheimer's disease
Analysis
Cancer
Central nervous system
Clinical trials
Degeneration
Enzymes
Erythropoiesis
Erythropoietin
Erythropoietin - administration & dosage
Erythropoietin - adverse effects
Female
Headache
Headaches
Health aspects
Healthy volunteers
Hematology
Humans
Hypoxia
Intranasal administration
Laboratory animals
Male
Mucosa
Nervous system
Nervous system diseases
Neurodegenerative diseases
NeuroEPO
Neurological diseases
Neuroprotection
Neuroprotective Agents - administration & dosage
Neuroprotective Agents - adverse effects
Non-hematopoietic recombinant erythropoietin
Recombinant Proteins - administration & dosage
Recombinant Proteins - adverse effects
Rodents
Safety
Side effects
Stroke
Stroke (Disease)
Studies
Young Adult
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Summary: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. 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
ISSN:1471-2377
1471-2377
DOI:10.1186/s12883-017-0908-0