drugset / Trial / NCT02414594
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a)
RandomizedSingle-groupDouble-blindOther
Summary
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.
Timeline
- Start
- 2015-04
- Primary completion
- 2016-02
- Completion
- 2016-02
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.
- Viney NJ, van Capelleveen JC, Geary RS, Xia S, Tami JA, Yu RZ, Marcovina SM, Hughes SG, Graham MJ, Crooke RM, Crooke ST, Witztum JL, Stroes ES, Tsimikas S. Antisense oligonucleotides targeting apolipoprotein(a) in people with raised lipoprotein(a): two randomised, double-blind, placebo-controlled, dose-ranging trials. Lancet. 2016 Nov 5;388(10057):2239-2253. doi: 10.1016/S0140-6736(16)31009-1. Epub 2016 Sep 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pelacarsen | Antisense oligonucleotide | 10 mg | Subcutaneous |
| Subject | Pelacarsen | Antisense oligonucleotide | 20 mg | Subcutaneous |
| Subject | Pelacarsen | Antisense oligonucleotide | 40 mg | Subcutaneous |
| Subject | Pelacarsen | Antisense oligonucleotide | 80 mg | Subcutaneous |
| Subject | Pelacarsen | Antisense oligonucleotide | 120 mg | Subcutaneous |