Status:
COMPLETED
Ascending Multiple Intravenous Doses of AON-D21 in Healthy Male Subjects.
Lead Sponsor:
Aptarion Biotech AG
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after multiple ascending intravenous doses of AON-D21 in healthy male subjects.
Detailed Description
This study will potentially include 2 two sequential cohorts with 8 healthy male subjects per cohort, then 16 enrolled subjects in total. Within each dose group 6 subjects will be randomized to receiv...
Eligibility Criteria
Inclusion
- 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Body mass index (BMI) within the range 18 - 30 kg/m2 with a body weight between 50 kg and 120 kg.
- Male subjects
- Subject is healthy as determined by medical evaluation
- Subject provided written informed consent
- Subject is willing to comply with all requirements and restrictions according to the study protocol.
Exclusion
- Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
- Any acquired or congenital immune deficiency.
- Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
- Clinically relevant abnormality following the Investigator's review of the physical examination, vital signs, ECG and clinical study protocol-defined clinical laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the trial at screening and admission.
- Evidence of COVID-19 signs or symptoms, exposure to infected person or confirmed COVID-19 infection within the last 2 weeks.
- Use of any concomitant medication or prescribed or non-prescribed drugs within 2 weeks or 5 times the half-life, whichever is longer, prior to the first study treatment administration.
- Administration of vaccine(s) within 2 weeks prior to screening or plans to receive such vaccines during the study.
- Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times, whichever is longer, prior to dosing.
- Positive drug or alcohol screen at screening and admission.
- Any significant blood loss, donated one unit (450 mL) of blood or more, or donated plasma, or received a transfusion of any blood or blood products within 30 days prior to dosing.
- Subjects who are unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice and /or pomelos, exotic citrus fruits, grapefruit hybrids, starfruit or fruit juices from 72 hours prior to dosing on Day 1, until completion of the last PK blood sample time point.
- Legal incapacity or limited legal capacity, or incarceration.
- Inability to understand or communicate reliably with the Investigator.
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05343819
Start Date
April 12 2022
End Date
November 29 2022
Last Update
December 19 2022
Active Locations (1)
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1
Nuvisan GmbH
Neu-Ulm, Germany, 89231