Investigation Of Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Doses Of Vupanorsen In Japanese Healthy Adult Participants With Elevated Triglycerides

Phase 1 Completed 12 enrolled Pfizer

RandomizedSequentialQuadruple-blindBasic science

Summary

This is a Phase 1, randomized, double blind, third party open (i.e., participant blind, investigator blind and sponsor open), placebo controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamics of vupanorsen in Japanese healthy adult participants with elevated triglycerides.

Timeline

Start: 2020-08-06
Primary completion: 2020-12-15
Completion: 2020-12-15

Publications

Fukuhara K, Furihata K, Matsuoka N, Itamura R, Ramos V, Hagi T, Kalluru H, Bramson C, Terra SG, Liu J. A multi-purpose Japanese phase I study in the global development of vupanorsen: Randomized, placebo-controlled, single-ascending dose study in adults. Clin Transl Sci. 2023 May;16(5):886-897. doi: 10.1111/cts.13498. Epub 2023 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vupanorsen	Unknown	80 mg	Subcutaneous
Subject	Vupanorsen	Unknown	160 mg	Subcutaneous

Indications

No indication recorded.