Safety and TolerabilityPhase 1NCT06331884
Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab)
A Phase 1 study testing AK1967 (Procizumab) in people with Safety and Tolerability and Healthy Volunteers, run by 4TEEN4 Pharmaceuticals GmbH at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability, Healthy Volunteers
- What is being tested?
- AK1967 (Procizumab)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Mar 2024to 4 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
- Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to the treatment day.
- Known or suspected of not being able to comply with the trial protocol.
- Known hypersensitivity or allergic reactions to drug compounds, (i.e. previous adverse drug reactions).
- Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525
About this study
Official title: Phase 1 Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of AK1967 (Procizumab) in Healthy Male Volunteers
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
- Being tested
- AK1967 (Procizumab), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK1967 (Procizumab)Drug
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
PlaceboDrug
Application of placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| AK1967 3 mg/kg/body weight | Active comparator | Not described Receives: Drug: AK1967 (Procizumab) |
| AK1967 6 mg/kg/body weight | Active comparator | Not described Receives: Drug: AK1967 (Procizumab) |
| AK1967 12 mg/kg/body weight | Active comparator | Not described Receives: Drug: AK1967 (Procizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Number of adverse events (AEs)
Measured: 28 days
Secondary outcomes (2)
Pharmacokinetics of AK1967 - t1/2
Pharmacokinetics of AK1967 - t1/2 (Half life)
Measured: 28-days
Pharmacokinetics of AK1967 - AUC
Pharmacokinetics of AK1967 - Area Under the Curve
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start7 Mar 2024
- Primary completion5 Aug 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety and TolerabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4TEEN4 Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331884
- Sponsor's protocol ID
- PCZ_Phase1
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2024
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Lier D, Genest M, Picod A, Manicone F, Garcia B, Uba TI, Schroeter A, Santos K, Herpain A, Nguyen A, Azibani F, Mebazaa A, Kox M, Pickkers P. Preclinical safety evaluation of the dipeptidyl peptidase 3 inhibiting antibody Procizumab in rodents and non-human primates. MAbs. 2026 Dec;18(1):2672800. doi: 10.1080/19420862.2026.2672800. Epub 2026 May 21.
PubMed 42166148
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of AK1967 (Procizumab) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT06331884
- Acronym / sponsor ID
- PCZ_Phase1
- Conditions
- Safety and Tolerability, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- 4TEEN4 Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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:
- Renal impairment: plasma creatinine >120 μmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK1967 (Procizumab)DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab) | Drug | AK1967 12 mg/kg/body weight, AK1967 3 mg/kg/body weight, AK1967 6 mg/kg/body weight |
| PlaceboApplication of placebo | Drug | Placebo |
Primary outcome
Safety and Tolerability
Time frame: 28 days
Number of adverse events (AEs)
2 secondary outcomes
Pharmacokinetics of AK1967 - t1/2
Time frame: 28-days
Pharmacokinetics of AK1967 - AUC
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42166148van Lier D, Genest M, Picod A, Manicone F, Garcia B, Uba TI, Schroeter A, Santos K, Herpain A, Nguyen A, Azibani F, Mebazaa A, Kox M, Pickkers P. Preclinical safety evaluation of the dipeptidyl peptidase 3 inhibiting antibody Procizumab in rodents and non-human primates. MAbs. 2026 Dec;18(1):2672800. doi: 10.1080/19420862.2026.2672800. Epub 2026 May 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK1967 (Procizumab) in people with Safety and Tolerability and Healthy Volunteers, run by 4TEEN4 Pharmaceuticals GmbH at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06331884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.