NCT06331884

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

Phase 1 Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of AK1967 (Procizumab) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: 4TEEN4 Pharmaceuticals GmbH · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	AK1967 (Procizumab)	DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
DRUG	Placebo	Application of placebo

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-08-05
• Completion: 2024-09-04
• First posted: 2024-03-26
• Last updated: 2026-02-27
• Results posted: 2025-07-20

Locations

1 site across 1 country: Netherlands