Clinical Study to Assess Safety, PK and PD Parameters of CDR132L

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess Safety, PK and PD Parameters of CDR132L in Patients With Stable Heart Failure of Ischemic Origin (NYHA 1- 3)

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: CDR132L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable heart failure of ischemic origin Exclusion Criteria: Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDR132L<br> | Drug: CDR132L<br>* i.v. administration<br>|
| Placebo Comparator: Saline<br> | Drug: CDR132L<br>* i.v. administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |