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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001291-10 | EudraCT Number |
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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).
Objectives:
Primary
• To assess the safety of one single and one repeated dose of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).
Secondary • To characterize the pharmacokinetic (PK) profile of CDR132L in patients with stable heart failure of ischemic origin.
Exploratory
• To determine the effect of CDR132L on pharmacodynamic (PD) parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDR132L | Experimental |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDR132L | Drug | i.v. administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events [safety and tolerability] | The incidence and severity of treatment-emergent adverse events (TEAEs) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Pharmacokinetics parameter derived by non-compartmental methods to measure maximum observed plasma concentration (Cmax) | 4 months |
| Time to reach maximum plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried Hauke, MD MFPM | Cardior Pharmaceuticals GmbH CMO | Study Director |
| Jorg Taubel, MD FFPM | Richmond Pharmacology Ltd CEO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge | London | SE1 1YR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33245749 | Derived | 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. | |
| 32105576 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Pharmacokinetics parameter derived by non-compartmental methods to measure time to maximum plasma concentration (Tmax)
| 4 months |
| Area under the curve (AUC0-t) | Pharmacokinetics parameter area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) | 4 months |
| Area under the curve (AUC0-inf) | Pharmacokinetics parameter area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) | 4 months |
| Blood clearance (CL) | Pharmacokinetics parameter to determin clearance considering terminal elimination rate | 4 months |
| Half life (t1/2) | Pharmacokinetics parameter to determin half-life rate (t1/2) | 4 months |
| Volume of distribution (Vdss) | Pharmacokinetics parameter | 4 months |
| Derived |
| 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. |