NCT04045405

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Cardior Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	CDR132L	i.v. administration

Timeline

• Start date: 2019-06-21
• Primary completion: 2020-01-31
• Completion: 2020-06-26
• First posted: 2019-08-05
• Last updated: 2026-01-09

Locations

1 site across 1 country: United Kingdom