drugset / Trial / NCT04045405
Clinical Study to Assess Safety, PK and PD Parameters of CDR132L
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).
Timeline
- Start
- 2019-06-21
- Primary completion
- 2020-01-31
- Completion
- 2020-06-26
Publications
- Taubel J, Hauke W, Rump S, Viereck J, Batkai S, Poetzsch J, Rode L, Weigt H, Genschel C, Lorch U, Theek C, Levin AA, Bauersachs J, Solomon SD, Thum T. Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study. Eur Heart J. 2021 Jan 7;42(2):178-188. doi: 10.1093/eurheartj/ehaa898.
- Huang CK, Kafert-Kasting S, Thum T. Preclinical and Clinical Development of Noncoding RNA Therapeutics for Cardiovascular Disease. Circ Res. 2020 Feb 28;126(5):663-678. doi: 10.1161/CIRCRESAHA.119.315856. Epub 2020 Feb 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CDR132L | Antisense oligonucleotide | 0.32 mg/kg | Intravenous |
| Subject | CDR132L | Antisense oligonucleotide | 1 mg/kg | Intravenous |
| Subject | CDR132L | Antisense oligonucleotide | 3 mg/kg | Intravenous |
| Subject | CDR132L | Antisense oligonucleotide | 10 mg/kg | Intravenous |