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

NCT ID: NCT04045405

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-21

Study Completion Date

2020-06-26

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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CDR132L

Group Type EXPERIMENTAL

CDR132L

Intervention Type DRUG

i.v. administration

Saline

Group Type PLACEBO_COMPARATOR

CDR132L

Intervention Type DRUG

i.v. administration

Interventions

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CDR132L

i.v. administration

Intervention Type DRUG

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),
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardior Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wilfried Hauke, MD MFPM

Role: STUDY_DIRECTOR

Cardior Pharmaceuticals GmbH CMO

Jorg Taubel, MD FFPM

Role: PRINCIPAL_INVESTIGATOR

Richmond Pharmacology Ltd CEO

Locations

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Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33245749 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32105576 (View on PubMed)

Other Identifiers

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2019-001291-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR132L-FIH01

Identifier Type: -

Identifier Source: org_study_id

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