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)
2 other identifiers
interventional
28
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 heart-failure
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2019
CompletedFirst Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2020
CompletedJanuary 9, 2026
January 1, 2026
7 months
July 23, 2019
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events [safety and tolerability]
The incidence and severity of treatment-emergent adverse events (TEAEs)
4 months
Secondary Outcomes (7)
Maximum plasma concentration (Cmax)
4 months
Time to reach maximum plasma concentration (Tmax)
4 months
Area under the curve (AUC0-t)
4 months
Area under the curve (AUC0-inf)
4 months
Blood clearance (CL)
4 months
- +2 more secondary outcomes
Study Arms (2)
CDR132L
EXPERIMENTALSaline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Stable heart failure of ischemic origin
You may not qualify if:
- Heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richmond Pharmacology Ltd., 1A Newcomen Street, London Bridge
London, SE1 1YR, United Kingdom
Related Publications (2)
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.
PMID: 33245749DERIVEDHuang 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.
PMID: 32105576DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wilfried Hauke, MD MFPM
Cardior Pharmaceuticals GmbH CMO
- PRINCIPAL INVESTIGATOR
Jorg Taubel, MD FFPM
Richmond Pharmacology Ltd CEO
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2019
First Posted
August 5, 2019
Study Start
June 21, 2019
Primary Completion
January 31, 2020
Study Completion
June 26, 2020
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share