Procizumab (PCZ; AK1967) in Critical Cardiovascular Care
Trial Parameters
Brief Summary
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
Inclusion Criteria: * Signed informed consent. * Diagnosis of CS due to ACS or CS of septic origin based on the following entry criteria: 1. Need for ongoing vasopressors and/or to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg 2. Serum lactate ≥ 2.0 mmol/L 3. Elevated DPP3 concentration Exclusion Criteria: * Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP. * Patients below the age of 18 or above 75 years. * Patients receiving Ang II and/or Levosimendan. * Patients with known allergies or hypersensitivity to the IMP or its excipients (including known lactose hypersensitivity) or any related medication. * Stroke or transient ischemic attack within the last 3 months. * SCAI Stage E or most severe SCAI D including circulatory collapse refractory to treatment and/or loss of consciousness. * Patients with SOFA score 12 and above in Part 1; SOFA score 14 and above in Part 2/3. * Patients on MCS. MCS includes any type of mechanical sup