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Safety, tolerability of ES16001, a novel varicella zoster virus reactivation inhibitor, in healthy adults

Cited 1 time in Web of Science Cited 1 time in Scopus
Issue Date
2021-08-12
Publisher
BMC
Citation
European Journal of Medical Research. 2021 Aug 12;26(1):92
Keywords
Elaeocarpus sylvestrisES16001Safety and tolerabilityVaricella zoster virus
Abstract
Purpose
Herpes zoster (HZ), or shingles, is a clinical syndrome resulting from the reactivation of latent varicella zoster virus (VZV) within the sensory ganglia. We evaluated the safety and tolerability of ES16001 (ethanol extract of Elaeocarpus sylvestris var. ellipticus), a novel inhibitor of varicella zoster virus reactivation in healthy adults.

Method
Single-center, randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) studies were conducted in 20- to 45-year-old healthy adults without chronic disease. In the SAD study (n = 32), subjects randomly received a single oral dose of 240, 480, 960, or 1440 mg ES16001 or a placebo. In the MAD study (n = 16), subjects randomly received once daily doses of 480 or 960 mg ES16001 or a placebo for 5 days. The safety and tolerability of the drug were evaluated by monitoring participants treatment emergent adverse events (TEAEs) and vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests.

Results
In the SAD study, 11 adverse reactions were seen in 5 subjects, and in the MAD study, 8 adverse reactions were seen in 6 subjects. All adverse reactions were mild, and no serious adverse reactions occurred. The most common adverse reaction was an increase in alanine aminotransferase (ALT), but all test values were in the clinically non-significant range, and their clinical significance was judged to be small considering the fact that most of the test values returned to normal immediately after the end of drug administration.

Conclusion
ES16001 has good safety and tolerability when administered both once and repeatedly to healthy subjects. Further research is needed to identify any possible drug-induced hepatotoxicity, which appears infrequently. Our findings provide a rationale for further clinical investigations of ES16001 for the prevention of HZ.
Trial registration: CRIS, KCT0006066. Registered 7 April 2021—Retrospectively registered,
https://cris.nih.go.kr/cris/search/detailSearch.do/19071).
ISSN
2047-783X
Language
English
URI
https://hdl.handle.net/10371/174845
DOI
https://doi.org/10.1186/s40001-021-00565-z
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College of Medicine/School of Medicine (의과대학/대학원)Program in Clinical Pharmacology (협동과정-임상약리학전공)Journal Papers (저널논문_협동과정-임상약리학전공)
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