Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants

Phase 1 Completed 16 enrolled Pfizer

RandomizedCrossoverTriple-blindBasic science

Summary

The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion.

Timeline

Start: 2020-10-23
Primary completion: 2020-12-17
Completion: 2020-12-17

Publications

Zhu T, Pawlak S, Toussi SS, Hackman F, Thompson K, Song W, Salageanu J, Winter E, Shi H, Winton J, Binks M. Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF-07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS-CoV-2, in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1382-1393. doi: 10.1002/cpdd.1174. Epub 2022 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	lufotrelvir	Small molecule	50 mg	Intravenous
Subject	lufotrelvir	Small molecule	150 mg	Intravenous
Subject	lufotrelvir	Small molecule	500 mg	Intravenous
Subject	lufotrelvir	Small molecule	700 mg	Intravenous

Indications

No indication recorded.