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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Application of placebo
Yerevan medical scientific center
Yerevan, Armenia
NOT_YET_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
Gad Cotter, MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Erebouni Mwdical Center
Yerevan, Armenia
NOT_YET_RECRUITINGHeart Center Aalst, AZORG
Aalst, Belgium
RECRUITINGUniversity Hospital Saint Pierre
Brussels, Belgium
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
RECRUITINGDépartement d'anesthésie-réanimation
Dijon, France
NOT_YET_RECRUITING...and 10 more locations