New antibody AK1967 tested in healthy men as potential shock therapy
NCT ID NCT06331884
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 1 study tested the safety and tolerability of a single intravenous dose of AK1967 (Procizumab) in 24 healthy male volunteers. AK1967 is an antibody that blocks a protein called DPP3, which may worsen blood pressure drops during cardiogenic shock. The study only looked at safety and how the drug moves through the body, not whether it works for shock.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK1967 (Procizumab)
- What this could lead to
- If successful, this could pave the way for a new treatment for cardiogenic shock by blocking a protein that worsens blood pressure instability.
- What could go wrong
- This is a very early Phase 1 study in only 24 healthy men, so it does not test if the drug works for shock. Safety and dosing are the only goals, and unexpected side effects may still appear.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Mar 2024
- Finished
-
Sep 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 35 years
- Sex
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Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Radboud University Medical Center
Nijmegen, Gelderland, 6525, Netherlands
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