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RECRUITING
NCT06832722
PHASE1/PHASE2

Procizumab (PCZ; AK1967) in Critical Cardiovascular Care

Sponsor: 4TEEN4 Pharmaceuticals GmbH

View on ClinicalTrials.gov

Summary

The objective of this Phase 1b trial is to evaluate the safety and tolerability of 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 procizumab are evaluated to define the optimum phase 2 dose (P2D) of procizumab.

Official title: Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1bTrial to Investigate Safety, Tolerability and Pharmacokinetics of Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-07-13

Completion Date

2026-04-01

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

AK1967 (Procizumab)

DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

DRUG

Placebo

Application of placebo

Locations (16)

Heart Center Aalst, AZORG

Aalst, Belgium

University Hospital Saint Pierre

Brussels, 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

University Hospital Lille - Institut Cœur Poumon

Lille, France

University Hospital - Dupuytren Limoges

Limoges, France

Regional University Hospital Nancy - Hopitaux de Brabois

Nancy, France

Lariboisière Hospital AP-HP

Paris, France

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