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

Recruiting Phase 1 Phase 2 Interventional Study
Shock, Cardiogenic
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
4TEEN4 Pharmaceuticals GmbH · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent. 2. Diagnosis of CS based on the following entry criteria: 1. Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg 2. Lactate ≥ 2.0 mmol/L 3. High cDPP3 concentration ≥ 30 ng/mL 3. Etiology of CS must be…
Contacts

Karakas Mahir, Prof. Dr. Dr.

+49 173 3060687

karakas@4teen4.de

CONTACT

Peter Szecsödy, MD

+46 707878737

szecsoedy@4teen4.de

CONTACT