Phase I Clinical Trial of SYL040012, a Small Interfering RNA Targeting β-Adrenergic Receptor 2, for Lowering Intraocular Pressure
| Autor: | Almudena Gomez-Guiu, Belén Sádaba, Ana Isabel Jimenez, María Victoria González, Javier Zarranz, Covadonga Pañeda, Veronica Ruz, Javier Moreno-Montañés |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Intraocular pressure Small interfering RNA Adolescent genetic structures Phases of clinical research Adrenergic Pharmacology Drug Administration Schedule Young Adult Drug Discovery Genetics Humans Medicine RNA Small Interfering Young adult Adverse effect Molecular Biology Intraocular Pressure business.industry eye diseases Clinical trial Treatment Outcome Anesthesia Molecular Medicine Original Article Female RNA Interference Receptors Adrenergic beta-2 sense organs β adrenergic receptor Ophthalmic Solutions business |
| Zdroj: | Molecular Therapy. 22:226-232 |
| ISSN: | 1525-0016 |
| DOI: | 10.1038/mt.2013.217 |
| Popis: | The objective of this study was to evaluate ocular tolerance, safety, and effect on intraocular pressure (IOP) of a topically administered small interfering RNA; SYL040012, on healthy volunteers. The study was an open-label, controlled, single-center study comprised of two intervals that enrolled 30 healthy subjects having IOP below 21 mmHg. SYL040012 was administered to one eye as a single dose to six subjects during interval 1. During interval 2 two different doses of SYL040012 were administered to one eye on a daily basis to two separate groups of 12 subjects each, over a period of 7 days. The contralateral eye was evaluated but not administered and served as control for the tolerance study. SYL040012 was well tolerated locally. No local or systemic adverse events related to the product developed in response to any of the doses studied. SYL040012 was not detected in plasma at any time point. Administration of SYL040012 over a period of 7 days reduced IOP values in 15 out of 24 healthy subjects regardless of the dose used. IOP decrease was statistically significant in response to one of the doses tested and responsiveness to SYL040012 seemed to be greater in individuals with higher baseline IOP. |
| Databáze: | OpenAIRE |
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