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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Application of placebo
Yerevan medical scientific center
Yerevan, Armenia
NOT_YET_RECRUITINGErebouni Mwdical Center
Yerevan, Armenia
NOT_YET_RECRUITINGHeart Center Aalst, AZORG
Aalst, Belgium
RECRUITINGUniversity Hospital Saint Pierre
Brussels, Belgium
RECRUITINGReported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration
Time frame: 30 days
Pharmacokinetics defined as plasma-time concentration of invobenitug
Time frame: 30 days
Pharmacodynamics defined as cDPP3 concentration
Time frame: 30 days
Pharmcodynamics defined as cDPP3 activity
Time frame: 30 days
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Ghent University Hospital
Ghent, Belgium
NOT_YET_RECRUITINGUniversity Hospital and Medical Faculty of Pilsen
Pilsen, Czechia
RECRUITINGCharles University Motol University Hospital
Prague, Czechia
RECRUITINGGeneral University Hospital in Prague - FVN
Prague, Czechia
RECRUITINGInstitute of Clinical and Experimental Medicine - IKEM
Prague, Czechia
RECRUITINGUniversity Hospital Avicenne AP-HP
Bobigny, France
RECRUITING...and 27 more locations