First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults
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- Mammen P. Mammen
- Vical Incorporated, San Diego, California, USA
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- Danielle Armas
- Celerion, Tempe, Arizona, USA
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- Frank H. Hughes
- Vical Incorporated, San Diego, California, USA
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- Andrew M. Hopkins
- Vical Incorporated, San Diego, California, USA
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- Cindy L. Fisher
- Vical Incorporated, San Diego, California, USA
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- Pamela A. Resch
- Vical Incorporated, San Diego, California, USA
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- Denis Rusalov
- Vical Incorporated, San Diego, California, USA
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- Sean M. Sullivan
- Vical Incorporated, San Diego, California, USA
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- Larry R. Smith
- Vical Incorporated, San Diego, California, USA
抄録
<jats:p> VL-2397 is an antifungal drug with a novel mechanism of action, rapid fungicidal <jats:italic>in vitro</jats:italic> activity, and potent <jats:italic>in vivo</jats:italic> activity against <jats:named-content content-type="genus-species">Aspergillus fumigatus</jats:named-content> , including azole-resistant strains. VL2397-101, a phase 1 first-in-human, randomized, double-blind, placebo-controlled dose-escalation study, was conducted in healthy adults to determine the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending intravenous (i.v.) doses of VL-2397. </jats:p>
収録刊行物
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- Antimicrobial Agents and Chemotherapy
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Antimicrobial Agents and Chemotherapy 63 (11), 2019-11
American Society for Microbiology