MedTrace Logo

Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab)

NCT06331884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-27

Study results available
· View outcomes & findings →

Summary

Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially life-saving response aimed at maintaining adequate tissue perfusion. As circulating (c)DPP3 is able to effectively cleave angiotensin II, it may represent a novel factor contributing to hemodynamic instability during cardiogenic shock.

Recently, a cDPP3-antagonizing antibody called AK1967 (commonly referred to as Procizumab) has been developed. In animal models of cardiogenic- and septic shock, inhibition of cDPP3 by AK1967 resulted in improved cardiac function and survival. Furthermore, AK1967 has shown an excellent safety record in different preclinical studies. In the current study the safety, tolerability and pharmacokinetics/-dynamics of AK1967 will be investigated in healthy male subjects.

Conditions

  • Safety and Tolerability
  • Healthy Volunteers

Interventions

DRUG

AK1967 (Procizumab)

DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

DRUG

Placebo

Application of placebo

Sponsors & Collaborators

  • 4TEEN4 Pharmaceuticals GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-08-05
Completion
2024-09-04

Countries

  • Netherlands

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 NCT06331884 on ClinicalTrials.gov