RecruitingPhase 1/2

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

Armenia, Belgium, Czechia130 participantsStarted 2025-07-13

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Signed informed consent.
✓. Diagnosis of CS based on the following entry criteria:
✓. Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg
✓. Lactate ≥ 2.0 mmol/L
✓. High cDPP3 concentration ≥ 30 ng/mL
✓. Etiology of CS must be one of the following: ACS, septic or adHF origin

Exclusion criteria

✕. Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
✕. Patients being longer than 24 hours in the ICU at the time of randomization.
✕. Patients below the age of 18 or above 80 years.
✕. Patients receiving Ang II and/or levosimendan.
✕. Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.
✕. Stroke or transient ischemic attack within the last 3 months.
✕0. SCAI Shock Stage E.
✕1. Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).

What they're measuring

Reported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration

Timeframe: 30 days

Trial details

NCT IDNCT06832722

Sponsor4TEEN4 Pharmaceuticals GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Karakas Mahir, Prof. Dr. Dr.

+49 173 3060687 karakas@4teen4.de

View on ClinicalTrials.gov More Shock, Cardiogenic trials