NCT06832722

Procizumab (PCZ; AK1967) in Critical Cardiovascular Care

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: 4TEEN4 Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shock, Cardiogenic

Interventions

Type	Name	Description
DRUG	AK1967 (Procizumab)	DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
DRUG	Placebo	Application of placebo

Timeline

• Start date: 2025-07-13
• Primary completion: 2026-03-31
• Completion: 2026-04-01
• First posted: 2025-02-18
• Last updated: 2026-01-28

Locations

16 sites across 5 countries: Belgium, Czechia, France, Netherlands, Poland