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

Launched by 4TEEN4 PHARMACEUTICALS GMBH · Mar 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called AK1967, also known as Procizumab, to see how safe it is and how the body responds to it. The drug is designed to help with heart function during serious conditions like cardiogenic shock, where the heart is unable to pump enough blood, which can be life-threatening. So far, in animal studies, it has shown promise in improving heart function and survival rates. The trial is currently looking for healthy male volunteers aged 18 to 35 who meet specific health criteria to participate.

Eligible participants will need to be in good health, without a history of heart problems or other significant medical issues. They should also be willing to avoid certain medications and alcohol during the study. Those who join the trial can expect to undergo various tests to ensure they are healthy before receiving the study drug. Overall, this trial aims to gather important information about AK1967's safety and how it works in the body, which could lead to better treatments for serious heart conditions in the future.

Gender

MALE

Eligibility criteria

• 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.