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)

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: CDR132L

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 1YR
    • Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Drug: CDR132L; i.v. administration
Experimental: CDR132L	Drug: CDR132L; i.v. administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cardior Pharmaceuticals GmbH
• Investigators: Study Director: Wilfried Hauke, MD MFPM, Cardior Pharmaceuticals GmbH CMO; Principal Investigator: Jorg Taubel, MD FFPM, Richmond Pharmacology Ltd CEO

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Estimated): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CDR132L-FIH01; 2019-001291-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No