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

NCT06331884 | Completed Phase 1 Results DMC

• 1 other identifier: PCZ_Phase1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Number of adverse events (AEs)

  28 days

Secondary Outcomes (2)

• Pharmacokinetics of AK1967 - t1/2

  28-days

• Pharmacokinetics of AK1967 - AUC

  28 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

AK1967 3 mg/kg/body weight

ACTIVE COMPARATOR

Drug: AK1967 (Procizumab)

AK1967 6 mg/kg/body weight

ACTIVE COMPARATOR

Drug: AK1967 (Procizumab)

AK1967 12 mg/kg/body weight

ACTIVE COMPARATOR

Drug: AK1967 (Procizumab)

Interventions

Placebo DRUG

Application of placebo

Placebo

AK1967 (Procizumab) DRUG

DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

AK1967 12 mg/kg/body weight; AK1967 3 mg/kg/body weight; AK1967 6 mg/kg/body weight

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent to participate in this trial prior to any study-mandated procedure.
• Male subjects aged 18 to 35 years inclusive.
• Subjects have to agree to use a reliable way of contraception with their partners from study entry until one month after study drug administration.
• BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg and an upper limit of 100 kg.
• Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters.

You may not qualify if:

• Unwillingness to abstain from any medication, including recreational drugs or vitamin supplements during the course of the study and within two days prior to the treatment day.
• Unwillingness to abstain from alcohol within one day prior to the treatment day until one day after the treatment day.
• Surgery or trauma with significant blood loss or blood donation within one month prior to the treatment day.
• History, signs or symptoms of cardiovascular disease, in particular:
• History of frequent vasovagal collapse or of orthostatic hypotension
• Resting pulse rate ≤45 or ≥100 beats/min
• Hypertension (RR systolic \>160 or RR diastolic \>90 mmHg)
• Hypotension (RR systolic \<100 or RR diastolic \<50 mmHg)
• Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
• Any chronic cardiac arrhythmias (except PAC's, PVC's)
• Renal impairment: plasma creatinine \>120 μmol/L
• Liver function tests (alkaline phosphatase, AST, ALT and/or γ-GT) above 2x the upper limit of normal.
• History of asthma
• Atopic constitution
• CRP above 2x the upper limit of normal, or clinically significant acute illness, including infections, within two weeks prior to the treatment day.

Sponsors & Collaborators

• 4TEEN4 Pharmaceuticals GmbH: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525, Netherlands

Location

MeSH Terms

Interventions

procizumab

Results Point of Contact

• Title: Kathleen Richter
• Organization: 4TEEN4 Pharmaceuticals

richter@4teen4.de

0049 1784027078

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: March 7, 2024
• Primary Completion: August 5, 2024
• Study Completion: September 4, 2024
• Last Updated: February 27, 2026
• Results First Posted: July 20, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)