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

Cardior Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: CDR132L

Study type: Interventional

Funder types: Industry

Identifiers

NCT04045405

CDR132L-FIH01

2019-001291-10 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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),

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

CDR132L

Experimental group

Treatment:

Drug: CDR132L

Saline

Placebo Comparator group

Treatment:

Drug: CDR132L