A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants

Phase 1 Completed 29 enrolled Ionis Pharmaceuticals, Inc.

RandomizedSequentialQuadruple-blindOther

Summary

The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple subcutaneous (SC) doses of Pelacarsen (ISIS 681257) in healthy Japanese participants.

Timeline

Start: 2018-10-15
Primary completion: 2019-12-18
Completion: 2019-12-18

Publications

Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pelacarsen	Antisense oligonucleotide	20 mg	Subcutaneous
Subject	Pelacarsen	Antisense oligonucleotide	40 mg	Subcutaneous
Subject	Pelacarsen	Antisense oligonucleotide	80 mg	Subcutaneous

Indications

No indication recorded.