Clinical trial • Phase II • Cardiology
Nucleic Acid for Heart failure with reduced ejection fraction (HFrEF) | Heart failure with mildly reduced ejection fraction (HFmrEF) | Left ventricular hypertrophy
Phase II trial of Nucleic Acid for Heart failure with reduced ejection fraction (HFrEF) | Heart failure with mildly reduced ejection fraction (HFmrEF) | L…
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Heart failure with reduced ejection fraction (HFrEF) | Heart failure with mildly reduced ejection fraction (HFmrEF) | Left ventricular hypertrophy
- Trial Stage
- Phase II
- Drug Modality
- Oligonucleotide
Key dates
- Initial CTIS Submission Date
- 07-02-2025
- First CTIS Authorization Date
- 26-05-2025
Trial design
Randomised, placebo q4w (placebo given every 4 weeks, matching schedule to active: placebo q4w).-controlled Phase II trial across 43 sites in Netherlands, Germany, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo Q4W (placebo given every 4 weeks, matching schedule to active: placebo Q4W).
- Target Sample Size
- 99
- Trial Duration For Participant
- 420
Eligibility
Recruits 99 No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent is required from adult participants; subject information and informed consent forms are provided (documents present in multiple languages for adult participants). No provisions for assent/minor consent are indicated in the application data..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent is required from adult participants; subject information and informed consent forms are provided (documents present in multiple languages for adult participants). No provisions for assent/minor consent are indicated in the application data.
Inclusion criteria
- {"criterion_text":"- 1. Age 40-84 years (both inclusive) at the time of signing the informed consent.\n- 2. Documented symptomatic HF diagnosed ≥180 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II−III at screening.\n- 3. Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation.\n- 4. LVEF <50% as assessed by echocardiography at screening, measured by central laboratory.\n- 5. Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following: a. LVMi >88 g/m2 for female participants and >102 g/m2 for male participants, using the truncated ellipsoid method. b. LVMi >95 g/m2 for female participants and >115 g/m2 for male participants, using the linear method (cube formula). c. Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) >3.1 cm/m2 for female participants and >3.0 cm/m2 for male participants.\n- 7. Body mass index 18.5-40 kg/m2 (both inclusive) and body weight ≤140 kg. Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1).\n- 8. NT-proBNP ≥300 pg/mL; NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory."}
Exclusion criteria
- {"criterion_text":"- 1. eGFR <30 mL/min/1.73 m2 at time of screening, measured by central laboratory.\n- 10. Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.\n- 2. Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation.\n- 3. Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening.\n- 4. Participants receiving intravenous HF medications within 45 days prior to randomisation.\n- 5. Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomisation.\n- 6. Stroke or transient ischemic attack within 12 months prior to randomisation.\n- 7. Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator.\n- 8. Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase >2.5x upper limit of normal at screening, measured by central laboratory.\n- 9. Known genetic (or highly suspected due to family history) cause of increased cardiac mass (including dilated cardiomyopathy, Fabry disease and likely pathogenic or pathogenic variants within hypertrophic cardiomyopathy [HCM]))."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit: Ratio to baseline","definition_or_measurement_approach":"Change in normalised miR-132 from baseline to week 24, measured as ratio to baseline (miR-132 normalisation as defined in protocol)."}
Secondary endpoints
- {"endpoint_text":"- Change in composite Z score based on the 3 outcome measures LVEDVi, LVESVi and NT-proBNP from baseline (V2) to week 24 (V14). Unit: Score","definition_or_measurement_approach":"Composite Z score based on LVEDVi, LVESVi and NT-proBNP from baseline to week 24; unit reported as score."}
- {"endpoint_text":"- Number of adverse events from baseline (V2) to week 24 (V14). Unit: Count","definition_or_measurement_approach":"Count of adverse events occurring from baseline to week 24."}
- {"endpoint_text":"- Number of adverse events from baseline (V2) to week 60 (V27). Unit: Count","definition_or_measurement_approach":"Count of adverse events occurring from baseline to week 60."}
Recruitment
- Planned Sample Size
- 99
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent obtained from each adult participant. Subject information and informed consent forms are provided for adult participants in multiple languages (English, Dutch, German, Spanish, Polish, Czech as evidenced by document set). No assent process for minors is indicated (trial enrols adults).
Methods
- Patient-facing trial recruitment advertisements and materials (country-specific patient adverts present for Germany, Spain, Poland, Czechia, Netherlands) as indicated by recruitment document titles.
- HCP-targeted recruitment materials (healthcare-professional adverts and referral information sheets present per country documents).
- Referral and transfer-of-contact-data materials to enable referral of potential participants (documents titled referral/transfer-of-contact-data).
- Participant study booklets, patient support network booklets and clinic-visit overview materials provided to support recruitment and participant information.
- Participant Infusion Test-specific recruitment advertisements (materials titled 'Participant Infusion Test' present).
Geography
- Total Number Of Sites
- 43
- Total Number Of Participants
- 113
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-05-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 184
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Erasmus MC_LOC#1
- Principal Investigator Name
- Rudolf De Boer
- Principal Investigator Email
- r.a.deboer@erasmusmc.nl
- Contact Person Name
- Rudolf De Boer
- Contact Person Email
- r.a.deboer@erasmusmc.nl
- Site Name
- Academisch Medisch Centrum
- Department Name
- Academisch Medisch Centrum
- Principal Investigator Name
- Ahmad Amin
- Principal Investigator Email
- a.s.amin@amsterdamumc.nl
- Contact Person Name
- Ahmad Amin
- Contact Person Email
- a.s.amin@amsterdamumc.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Zuyderland ziekenhuis_LOC#1
- Principal Investigator Name
- Mark Hazebroek
- Principal Investigator Email
- Rd-cardiology@zuyderland.nl
- Contact Person Name
- Mark Hazebroek
- Contact Person Email
- Rd-cardiology@zuyderland.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Radboudumc
- Principal Investigator Name
- Carlijne Hassing
- Principal Investigator Email
- Carlijne.Hassing@radboudumc.nl
- Contact Person Name
- Carlijne Hassing
- Contact Person Email
- Carlijne.Hassing@radboudumc.nl
- Site Name
- Stichting Viecuri Medisch Centrum voor Noord-Limburg
- Department Name
- VieCuri
- Principal Investigator Name
- Wouter Remkes
- Principal Investigator Email
- wremkes@viecuri.nl
- Contact Person Name
- Wouter Remkes
- Contact Person Email
- wremkes@viecuri.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 22-04-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 343
- Number Of Sites
- 9
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
- Principal Investigator Name
- Tienush Rassaf
- Principal Investigator Email
- tienush.rassaf@uk-essen.de
- Contact Person Name
- Tienush Rassaf
- Contact Person Email
- tienush.rassaf@uk-essen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
- Principal Investigator Name
- Johann Bauersachs
- Principal Investigator Email
- bauersachs.johann@mh-hannover.de
- Contact Person Name
- Johann Bauersachs
- Contact Person Email
- bauersachs.johann@mh-hannover.de
- Site Name
- Universitaetsklinikum Halle (Saale) AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin III, UK Halle
- Principal Investigator Name
- Daniel Sedding
- Principal Investigator Email
- Daniel.Sedding@uk-halle.de
- Contact Person Name
- Daniel Sedding
- Contact Person Email
- Daniel.Sedding@uk-halle.de
- Site Name
- Herzzentrum Dresden GmbH Universitaetsklinik
- Department Name
- Herzzentrum Dresden GmbH Universitätsklinik
- Principal Investigator Name
- Ephraim Winzer
- Principal Investigator Email
- ephraim.winzer@tu-dresden.de
- Contact Person Name
- Ephraim Winzer
- Contact Person Email
- ephraim.winzer@tu-dresden.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
- Principal Investigator Name
- Norbert Frey
- Principal Investigator Email
- Norbert.Frey@med.uni-heidelberg.de
- Contact Person Name
- Norbert Frey
- Contact Person Email
- Norbert.Frey@med.uni-heidelberg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Charité B.Franklin Kardio + Hämatologie
- Principal Investigator Name
- Ursula Rauch-Kröhnert
- Principal Investigator Email
- ursula.rauch@dhzc-charite.de
- Contact Person Name
- Ursula Rauch-Kröhnert
- Contact Person Email
- ursula.rauch@dhzc-charite.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Uni Frankfurt, Kardiologie_LOC#1
- Principal Investigator Name
- Maria Papathanasiou
- Principal Investigator Email
- maria.papathanasiou@unimedizin-ffm.de
- Contact Person Name
- Maria Papathanasiou
- Contact Person Email
- maria.papathanasiou@unimedizin-ffm.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR (Campus Virchow-Klinikum)
- Department Name
- Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
- Principal Investigator Name
- Frank Edelmann
- Principal Investigator Email
- frank.edelmann@dhzc-charite.de
- Contact Person Name
- Frank Edelmann
- Contact Person Email
- frank.edelmann@dhzc-charite.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Kardiologie und Internistische Intensivmedizin Kiel
- Principal Investigator Name
- Derk Frank
- Principal Investigator Email
- derk.frank@uksh.de
- Contact Person Name
- Derk Frank
- Contact Person Email
- derk.frank@uksh.de
Spain
- Earliest CTIS Part Ii Submission Date
- 26-02-2025
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 435
- Number Of Sites
- 12
- Number Of Participants
- 22
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Hospital del Mar
- Principal Investigator Name
- Sonia Ruiz Bustillo
- Principal Investigator Email
- sruiz@psmar.cat
- Contact Person Name
- Sonia Ruiz Bustillo
- Contact Person Email
- sruiz@psmar.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Hospital Clínico Universitario de Valencia
- Principal Investigator Name
- Julio Núñez Villota
- Principal Investigator Email
- juenuvi@uv.es
- Contact Person Name
- Julio Núñez Villota
- Contact Person Email
- juenuvi@uv.es
- Site Name
- Hospital De Denia
- Department Name
- Cardiology Department
- Principal Investigator Name
- Alfonso Valle
- Principal Investigator Email
- dr.alfonsovalle@gmail.com
- Contact Person Name
- Alfonso Valle
- Contact Person Email
- dr.alfonsovalle@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Hospital Clínico Virgen de la Victoria
- Principal Investigator Name
- Jose Manuel Garcia Pinilla
- Principal Investigator Email
- eecccardiohuvv@gmail.com
- Contact Person Name
- Jose Manuel Garcia Pinilla
- Contact Person Email
- eecccardiohuvv@gmail.com
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Hospital Universitario de Gerona Doctor Josep Trueta
- Principal Investigator Name
- Aleix Fort
- Principal Investigator Email
- afort.girona.ics@gencat.cat
- Contact Person Name
- Aleix Fort
- Contact Person Email
- afort.girona.ics@gencat.cat
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Hospital Virgen de la Arrixaca
- Principal Investigator Name
- Domingo Pascual Figal
- Principal Investigator Email
- dpascual@um.es
- Contact Person Name
- Domingo Pascual Figal
- Contact Person Email
- dpascual@um.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hospital Virgen del Rocío
- Principal Investigator Name
- Antonio Grande Trillo
- Principal Investigator Email
- trillo_87@hotmail.com
- Contact Person Name
- Antonio Grande Trillo
- Contact Person Email
- trillo_87@hotmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Hospital Universitario La Paz
- Principal Investigator Name
- María Isabel Antorrena Miranda
- Principal Investigator Email
- iantorrena@hotmail.com
- Contact Person Name
- María Isabel Antorrena Miranda
- Contact Person Email
- iantorrena@hotmail.com
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Hospital Universitario de Gran Canaria Doctor Negrín
- Principal Investigator Name
- Antonio García Quintana
- Principal Investigator Email
- uichugcdn.scs@gobiernodecanarias.org
- Contact Person Name
- Antonio García Quintana
- Contact Person Email
- uichugcdn.scs@gobiernodecanarias.org
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Hospital Universitario San Cecilio - Cardiology
- Principal Investigator Name
- Jesús Gabriel Sánchez Ramos
- Principal Investigator Email
- cardiopac.husc.sspa@juntadeandalucia.es
- Contact Person Name
- Jesús Gabriel Sánchez Ramos
- Contact Person Email
- cardiopac.husc.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Servicio de cardiología
- Principal Investigator Name
- Marta Cobo Marcos
- Principal Investigator Email
- martacobomarcos@hotmail.com
- Contact Person Name
- Marta Cobo Marcos
- Contact Person Email
- martacobomarcos@hotmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Cardiología
- Principal Investigator Name
- Marta Jiménez-Blanco Bravo
- Principal Investigator Email
- marta.jimenez-blanco@salud.madrid.org
- Contact Person Name
- Marta Jiménez-Blanco Bravo
- Contact Person Email
- marta.jimenez-blanco@salud.madrid.org
Poland
- Earliest CTIS Part Ii Submission Date
- 21-05-2025
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 359
- Number Of Sites
- 12
- Number Of Participants
- 32
Sites
- Site Name
- 1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie
- Department Name
- 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
- Principal Investigator Name
- Grzegorz Sobieszek
- Principal Investigator Email
- cwbk@1wszk.pl
- Contact Person Name
- Grzegorz Sobieszek
- Contact Person Email
- cwbk@1wszk.pl
- Site Name
- Pomeranian Medical University
- Department Name
- Centrum Wsparcia Badan Klinicznych PUM
- Principal Investigator Name
- Piotr Gościniak
- Principal Investigator Email
- piotrgosciniak1@gmail.com
- Contact Person Name
- Piotr Gościniak
- Contact Person Email
- piotrgosciniak1@gmail.com
- Site Name
- American Heart Of Poland S.A.
- Department Name
- Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej
- Principal Investigator Name
- Krzysztof Milewski
- Principal Investigator Email
- krzysztof.milewski@ahop.pl
- Contact Person Name
- Krzysztof Milewski
- Contact Person Email
- krzysztof.milewski@ahop.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Kardiologii i Chorób Wewnętrznych z OINK
- Principal Investigator Name
- Anna Lisowska
- Principal Investigator Email
- anlila@poczta.onet.pl
- Contact Person Name
- Anna Lisowska
- Contact Person Email
- anlila@poczta.onet.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Zakład Badań Klinicznych Chorób Układu Krążenia
- Principal Investigator Name
- Joanna Szachniewicz
- Principal Investigator Email
- jszachniewicz@gmail.com
- Contact Person Name
- Joanna Szachniewicz
- Contact Person Email
- jszachniewicz@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Centrum Innowacyjnych Terapii
- Principal Investigator Name
- Lukasz Wisniowski
- Principal Investigator Email
- drlukaszwisniowski@gmail.com
- Contact Person Name
- Lukasz Wisniowski
- Contact Person Email
- drlukaszwisniowski@gmail.com
- Site Name
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Department Name
- Narodowy Instytut Kardiologii, Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Artur Oręziak
- Principal Investigator Email
- aoreziak@ikard.pl
- Contact Person Name
- Artur Oręziak
- Contact Person Email
- aoreziak@ikard.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Klinika Kardiologii Interwencyjnej
- Principal Investigator Name
- Jakub Podolec
- Principal Investigator Email
- jakub.podolec@uj.edu.pl
- Contact Person Name
- Jakub Podolec
- Contact Person Email
- jakub.podolec@uj.edu.pl
- Site Name
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
- Department Name
- Oddz.Kardiologii z pododdz. INK, pododdz. Kardiologii Inwazyjnej, pododdz. Kardiochirurgii
- Principal Investigator Name
- Lukasz Wisniowski
- Principal Investigator Email
- drlukaszwisniowski@gmail.com
- Contact Person Name
- Lukasz Wisniowski
- Contact Person Email
- drlukaszwisniowski@gmail.com
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw
- Department Name
- Osrodek Chorob Serca
- Principal Investigator Name
- Bartosz Krakowiak
- Principal Investigator Email
- badaniakliniczne@4wsk.pl
- Contact Person Name
- Bartosz Krakowiak
- Contact Person Email
- badaniakliniczne@4wsk.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
- Department Name
- Ośrodek Innowacyjnych Terapii
- Principal Investigator Name
- Piotr Macioch
- Principal Investigator Email
- piotr.macioch@gmail.com
- Contact Person Name
- Piotr Macioch
- Contact Person Email
- piotr.macioch@gmail.com
- Site Name
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
- Department Name
- Oddział Kardiologii i Chorób Wewnętrznych
- Principal Investigator Name
- Piotr Rychlak
- Principal Investigator Email
- petrus_r@o2.pl
- Contact Person Name
- Piotr Rychlak
- Contact Person Email
- petrus_r@o2.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 01-05-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 349
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Pratia Prague s.r.o.
- Department Name
- Pratia Prague s.r.o.
- Principal Investigator Name
- Tamilla Muzafarova
- Principal Investigator Email
- tamilla.muzafarova@pratia.com
- Contact Person Name
- Tamilla Muzafarova
- Contact Person Email
- tamilla.muzafarova@pratia.com
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- Kardiocentrum IKEM
- Principal Investigator Name
- Vojtěch Melenovský
- Principal Investigator Email
- vome@ikem.cz
- Contact Person Name
- Vojtěch Melenovský
- Contact Person Email
- vome@ikem.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Fakultní Nemocnice Ostrava
- Principal Investigator Name
- Jan Václavík
- Principal Investigator Email
- jan.vaclavik@fno.cz
- Contact Person Name
- Jan Václavík
- Contact Person Email
- jan.vaclavik@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- interní klinika kardiologie a angiologie
- Principal Investigator Name
- Daniel Rob
- Principal Investigator Email
- daniel.rob@vfn.cz
- Contact Person Name
- Daniel Rob
- Contact Person Email
- daniel.rob@vfn.cz
- Site Name
- Nemocnice Ceske Budejovice a.s.
- Department Name
- Nemocnice Ceske Budejovice, a.s. Kardiologicke oddeleni
- Principal Investigator Name
- Aleš Kovářík
- Principal Investigator Email
- kovarik.ales@nemcb.cz
- Contact Person Name
- Aleš Kovářík
- Contact Person Email
- kovarik.ales@nemcb.cz
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Icon (Lr) Limited
- Responsibilities
- Imaging Service
- Name
- IQVIA Limited
- Name
- Iqvia Rds Ireland Limited
- Responsibilities
- ECG
Third parties
- {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"DMC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Packaging and Labelling QP oversight UK","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"FyoniBio GmbH","duties_or_roles":"immunogenicity","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Imaging Service","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Denmark","full_name":"KLIFO A/S","duties_or_roles":"Equipment, Pump, Syringe, and Tube","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Iqvia Rds Ireland Limited","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM/IWRS supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"miR-132 assay","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Axolabs GmbH","duties_or_roles":"Pharmacokinetics","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Proteomics","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- CDR132L (sponsor product code CDR132L A 10043)
- Active Substance
- Nucleic Acid
- Modality
- Oligonucleotide
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Starting Dose
- 00 mg/kg
- Frequency
- Q4W
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