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
Heart Center Aalst, AZORG
Aalst, Belgium
RECRUITINGUniversity Hospital Saint Pierre
Brussels, Belgium
Reported number of treatment-emergent adverse events from start of Procizumab administration up until the last follow-up visit after Procizumab administration
Time frame: 30 days
Pharmacokinetics defined as plasma-time concentration of procizumab
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
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