Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1bTrial to Investigate Safety, Tolerability and Pharmacokinetics of Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Signed informed consent.
• Diagnosis of CS due to ACS or CS of septic origin based on the following entry criteria:
‣ Need for ongoing vasopressors to maintain a MAP ≥ 65 mm ≥ or SBP ≥ 90 mmHg
⁃ Serum lactate ≥ 2.0 mmol/L
⁃ Elevated DPP3 concentration
Locations
Other Locations
Belgium
University Hospital Saint Pierre
RECRUITING
Brussels
France
University Hospital Avicenne AP-HP
RECRUITING
Bobigny
University Hospital Lille - Institut Cœur Poumon
RECRUITING
Lille
University Hospital - Dupuytren Limoges
RECRUITING
Limoges
Regional University Hospital Nancy - Hopitaux de Brabois
RECRUITING
Nancy
Lariboisière Hospital AP-HP
RECRUITING
Paris
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Poland
Clinical University Hospital Poznań
RECRUITING
Poznan
J. Mikulicz Radecki Clinical University Hospital Wrocław
RECRUITING
Wroclaw
Contact Information
Primary
Karakas Mahir, Prof. Dr. Dr.
marschner@4teen4.de
+49 173 3060687
Backup
Gad Cotter, MD
Time Frame
Start Date: 2025-07-13
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 130
Treatments
Active_comparator: Procizumab (AK1967) 10mg/kg body weight
10 mg/kg body weight
Active_comparator: Procizumab (AK1967) other dose regimen based on PK profile
Other dose regimen based on PK profile
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: 4TEEN4 Pharmaceuticals GmbH