RecruitingPhase 1Phase 2NCT06832722

Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care

Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b/2a Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Invobenitug Also Knows as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations


Sponsor

4TEEN4 Pharmaceuticals GmbH

Enrollment

90 participants

Start Date

Jul 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AK1967 (Invobenitug also known as Procizumab) and a drug called Placebo for people with shock, cardiogenic. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK1967 (Invobenitug also known as Procizumab)

DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

DRUGPlacebo

Application of placebo


Locations(25)

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

Radboud University Medical Center

Nijmegen, Netherlands

Uniersytecki Szpital Kliniczny w Białystoku

Bialystok, Poland

Uniwersytecki Szpital Kliniczny w Białymstoku

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

View Full Details on ClinicalTrials.gov

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NCT06832722


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