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A Phase 1b/2a Trial to Evaluate Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care.
Sponsor: 4TEEN4 Pharmaceuticals GmbH
Summary
The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.
Official title: Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b/2a Trial to Investigate Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Invobenitug Also Known as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-07-13
Completion Date
2026-12-31
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
AK1967 (Invobenitug also known as Procizumab)
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Placebo
Application of placebo
Locations (37)
Yerevan medical scientific center
Yerevan, Armenia
Erebouni Mwdical Center
Yerevan, Armenia
Heart Center Aalst, AZORG
Aalst, Belgium
University Hospital Saint Pierre
Brussels, Belgium
Ghent University Hospital
Ghent, Belgium
University Hospital and Medical Faculty of Pilsen
Pilsen, Czechia
Charles University Motol University Hospital
Prague, Czechia
General University Hospital in Prague - FVN
Prague, Czechia
Institute of Clinical and Experimental Medicine - IKEM
Prague, Czechia
University Hospital Avicenne AP-HP
Bobigny, France
Département d'anesthésie-réanimation
Dijon, France
University Hospital Lille - Institut Cœur Poumon
Lille, France
University Hospital - Dupuytren Limoges
Limoges, France
Regional University Hospital Nancy - Hopitaux de Brabois
Nancy, France
Hôpital Pitié Salpêtrière
Paris, France
Lariboisière Hospital AP-HP
Paris, France
Deutsches Herzzentrum der Charite (DHZC)
Berlin, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Universitätsmedizin Mannheim
Mannheim, Germany
Radboud University Medical Center
Nijmegen, Netherlands
Uniersytecki Szpital Kliniczny w Białystoku
Bialystok, Poland
Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach
Katowice, Poland
Clinical University Hospital Poznań
Poznan, Poland
J. Mikulicz Radecki Clinical University Hospital Wrocław
Wroclaw, Poland
Clinical Hospital Center Bezanijska Kosa
Belgrade, Serbia
Institute for Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia
Clinical Center Niš
Niš, Serbia
Fundación Pública Galega de Investigación Biomédica INIBIC
A Coruña, Spain
Fundació Hospital Universitari Vall d'Hebron
Barcelona, Spain
Fundació Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
L'Hospitalet de Llobregat
Barcelona, Spain
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain