Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care
ConditionShock, Cardiogenic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
Sponsor4TEEN4 Pharmaceuticals GmbH
About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent.
Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg
Lactate ≥ 2.0 mmol/L
High cDPP3 concentration ≥ 30 ng/mL
Disqualifiers
Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
Patients being longer than 24 hours in the ICU at the time of randomization.
Patients below the age of 18 or above 80 years.
Patients receiving Ang II and/or levosimendan.
Trial design
Treatments tested in this trial
- AK1967 (Invobenitug also known as Procizumab)
- Placebo
Treatment groups
130 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov