Safety and Pharmacokinetics of LHF-535, a Potential Treatment for Lassa Fever, in Healthy Adults.
Antimicrob Agents Chemother
; 66(11): e0095122, 2022 11 15.
Article
in En
| MEDLINE
| ID: mdl-36314868
ABSTRACT
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 (n = 2) or LHF-535 (n = 6). LHF-535 was well tolerated in both studies. Treatment-emergent adverse events were more frequent in placebo recipients than in LHF-535 recipients in both studies. LHF-535 exhibited rapid absorption, a long half-life, and exposures predicted to suppress viral replication.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Hemorrhagic Fevers, Viral
/
Lassa Fever
Type of study:
Clinical_trials
Limits:
Adult
/
Humans
Language:
En
Journal:
Antimicrob Agents Chemother
Year:
2022
Document type:
Article
Affiliation country:
United States