Phase 1b2a Study to Test Safety and Effects of Invobenitug Procizumab in Adults With Cardiogenic Shock and High cDPP3 Levels

What this Trial Is About

Researchers are evaluating invobenitug also known as procizumab, a monoclonal antibody, for treating cardiogenic shock CS, a dangerous condition where vital organs receive insufficient blood flow. This Phase 1b2a trial focuses on assessing the safety, tolerability, and exploratory effectiveness of invobenitug. The study also measures how the drug behaves in the body to determine the best dose for future phases. Participants receive either invobenitug or a placebo in a randomized, double-blind setup. The drug is given at a dose of 10 mgkg body weight. The trial evaluates key factors such as pharmacokinetics, pharmacodynamics including circulating dipeptidyl peptidase 3 cDPP3 levels and activity, and safety over a 30-day period following administration. During the study, participants are closely monitored for treatment-emergent adverse events and changes in drug concentration and activity in the blood. The trial includes follow-up visits up to 30 days after treatment to assess safety and drug effects. This process helps researchers gather important information about the drugs impact and tolerability in patients with cardiogenic shock.

Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care