A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending and Multiple Doses of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Healthy Japanese Participants

NCT04302064 ↗

Phase 1 Completed 24 enrolled Ionis Pharmaceuticals, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate the safety and tolerability of single and potentially multiple doses of Eplontersen administered subcutaneously (SC) to healthy Japanese participants.

Timeline

Start: 2020-04-23
Primary completion: 2020-09-10
Completion: 2020-09-10

Publications

Diep JK, Yu RZ, Viney NJ, Schneider E, Guo S, Henry S, Monia B, Geary R, Wang Y. Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis. Br J Clin Pharmacol. 2022 Dec;88(12):5389-5398. doi: 10.1111/bcp.15468. Epub 2022 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eplontersen	Antisense oligonucleotide	—	Subcutaneous

Indications

No indication recorded.