Safety and Pharmacokinetics of LHF-535, a Potential Treatment for Lassa Fever, in Healthy Adults

Autor:	Sean M. Amberg, Benjamin Snyder, Portia A. Vliet-Gregg, Eric J. Tarcha, Jeff Posakony, Kristin M. Bedard, Alison E. Heald
Rok vydání:	2022
Předmět:	Adult Pharmacology Lassa Fever Hemorrhagic Fevers Viral Infectious Diseases Double-Blind Method Dose-Response Relationship Drug Humans Pharmacology (medical) Antiviral Agents Healthy Volunteers
Zdroj:	Antimicrobial Agents and Chemotherapy. 66
ISSN:	1098-6596 0066-4804
DOI:	10.1128/aac.00951-22
Popis:	LHF-535 is a small-molecule antiviral currently under development as a therapeutic option to treat Lassa fever and other viral hemorrhagic fevers of arenavirus origin. The human safety and pharmacokinetics of LHF-535 were evaluated in two phase 1 trials in healthy volunteers. The first study was a double-blind, single ascending dose trial that evaluated weight-based oral doses ranging from 0.3 mg/kg in the first cohort to 40 mg/kg in the last cohort. The second study was a double-blind, multiple ascending dose trial that evaluated a 14-day oral dosing regimen, with three sequential cohorts receiving fixed doses of 450, 900, or 1,125 mg per day; the third cohort (1,125 mg/day) received a higher (loading) dose of 2,250 mg for the first dose. Each cohort in both studies consisted of eight participants randomized to either placebo (
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8ee70a7e7dc7162fe40f9eee48141621 https://doi.org/10.1128/aac.00951-22 Zobrazit plný text záznamu