First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults
Year: 2019
Type: article
Study design: Clinical Trial
Abstract: ). No signs of VL-2397 accumulation were observed following i.v. infusions of 300, 600, and 1,200 mg every 24 h (q24h) for 7 days. Renal elimination played a major role in total body clearance, with up to 47% of unmetabolized drug in urine 24 h after administration at single doses of >30 mg. Overall, VL-2397 dosing in the study appeared to be safe and well tolerated in the healthy subjects. The safety profile, consistent PK, and lack of drug accumulation support further development of VL-2397 in patients with invasive aspergillosis.
DOI: 10.1128/aac.00969-19
Authors: Mammen P. Mammen, Danielle Armas, Frank H. Hughes, Andrew M. Hopkins, Cindy L. Fisher, Pamela A. Resch, Denis Rusalov, Sean M. Sullivan, Larry R. Smith
Institutions: Vical (United States), Celerion (United States)
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2969304222