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

NCT06832722 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-09

No results posted yet for this study

Summary

The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as 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 invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.

Conditions

  • Shock, Cardiogenic

Interventions

DRUG

AK1967 (Invobenitug also known as Procizumab)

DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

DRUG

Placebo

Application of placebo

Sponsors & Collaborators

  • 4TEEN4 Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Alexandre Mebazaa, Professor · Hôpital Lariboisière, Paris France

  • David A. Morrow, MD, MPH · TIMI study Group (An ARO of Brigham & Women's Hospital and an Affiliate of Harvard Medical School)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-13
Primary Completion
2026-12-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Armenia
  • Belgium
  • Czechia
  • France
  • Netherlands
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832722 on ClinicalTrials.gov