Abstract
PurposeHerpes 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.MethodSingle-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.ResultsIn 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.ConclusionES16001 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).
Highlights
Varicella zoster virus (VZV) is generally a childhood infection and causes chickenpox
Our findings provide a rationale for further clinical investigations of ES16001 for the prevention of Herpes zoster (HZ)
The manufacturing process was in accordance with the good manufacturing process (GMP) standards, and the drugs were delivered and stored according to the manufacturer’s instructions
Summary
Varicella zoster virus (VZV) is generally a childhood infection and causes chickenpox. It moves along the entire nerve axis in the body and hides in the dorsal root ganglion, cranial ganglion, and autonomic ganglion, and can reactivate when the host’s immunity decreases, causing shingles [1]. This clinical form of shingles is characterized by a painful, unilateral vesicular eruption, which. The recurrence rate of shingles is reported to be about 5% or more; it is a difficult disease to treat because existing shingles treatments cannot block the reactivation of the virus latent in the ganglion [3]. Inhibition of VZV reactivation is known to be an important factor in the treatment of shingles
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