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

Content Provider	Springer Nature : BioMed Central
Author	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
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 <10% of severe adverse reactions in the evaluated groups. Therefore, a rigorous assessment of possible adverse events was carried out, which included tolerance of the nasal mucosa and the effect on hematopoietic activity. Clinical safety evaluation was daily during treatment and laboratory tests were done before and on days 5 and 14 after starting treatment. Results Twenty-five volunteers, 56% women, with a mean age of 27 yrs. were included. Twelve of them received the highest NeuroEPO dose. Twenty types of adverse events occurred, with headache (20%) and increase of hepatic enzymes (20%) as the most reported ones. Nasopharyngeal itching was the most common local event but only observed in four patients (16%), all of them from the lowest dose group. About half of the events were very probably or probably caused by the studied product. Most of the events were mild (95.5%), did not require treatment (88.6%) and were completely resolved (81.8%). No severe adverse events were reported. During the study the hematopoietic variables were kept within reference values. Conclusions NeuroEPO was a safe product, well tolerated at the nasal mucosa level and did not stimulate erythropoiesis in healthy volunteers. Trial registration Cuban Public Registry of Clinical Trials RPCEC00000157 , June 10, 2013.
Related Links	https://bmcneurol.biomedcentral.com/counter/pdf/10.1186/s12883-017-0908-0.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14712377
DOI	10.1186/s12883-017-0908-0
Journal	BMC Neurology
Issue Number	1
Volume Number	17
Language	English
Publisher	BioMed Central
Publisher Date	2017-07-04
Access Restriction	Open
Subject Keyword	Neurology Neurochemistry Neurosurgery Non-hematopoietic recombinant erythropoietin NeuroEPO Stroke Neurodegenerative diseases Healthy volunteers Safety Hematopoietic activity
Content Type	Text
Resource Type	Article
Subject	Neurology (clinical)
Journal Impact Factor	2.2/2023
5-Year Journal Impact Factor	2.5/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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