A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Single Dose Vupanorsen In Healthy Chinese Adults

Phase 1 Completed 18 enrolled Pfizer

RandomizedParallel-groupOpen-labelBasic science

Summary

This is a Phase 1, randomized, parallel-cohort, open-label study to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of vupanorsen following 80 mg and 160 mg single subcutaneous dose in healthy Chinese adults with elevated fasting triglyceride.

Timeline

Start: 2021-06-17
Primary completion: 2021-10-19
Completion: 2021-10-19

Publications

Wu X, Yu J, Ge B, Wang J, Han X, Zhang C, Mao X, Kalluru H, Bramson C, Terra SG, Liu J. A Randomized, Open-Label, Phase I, Single-Dose Study of Antisense Oligonucleotide, Vupanorsen, in Chinese Adults with Elevated Triglycerides. Drugs R D. 2024 Jun;24(2):253-262. doi: 10.1007/s40268-024-00467-5. Epub 2024 Jul 1.

Drugs

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

Indications

No indication recorded.