Trial | NCT04045405  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    28
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.
Study Started
Jun 21
2019
Primary Completion
Jan 31
2020
Study Completion
Jun 26
2020
Last Update
Mar 09
2022

Drug CDR132L

i.v. administration

CDR132L Experimental

Saline Placebo Comparator

Criteria 

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),
No Results Posted