Health Trials

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

ConditionShock, Cardiogenic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
Sponsor4TEEN4 Pharmaceuticals GmbH

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 of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK1967 (Invobenitug also known as Procizumab)

    Drug

    DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

  • Placebo

    Drug

    Application of placebo

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weightActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days

Secondary outcomes

1

Pharmacokinetics defined as plasma-time concentration of invobenitug

Time frame
30 days
2

Pharmacodynamics defined as cDPP3 concentration

Time frame
30 days
3

Pharmcodynamics defined as cDPP3 activity

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

4TEEN4 Pharmaceuticals GmbH

Lead sponsor

Source ClinicalTrials.gov
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