A Randomized, Single-center, Double-blind, Placebo Controlled, First-in-human Trial With Single Ascending Intravenous Doses to Determine Safety, Tolerability and Pharmacokinetics of AON-D21 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Intravenous AON-D21
- Conditions
- Healthy
- Sponsor
- Aptarion Biotech AG
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Primary Safety Endpoint - Per Dosing Cohort number of participants with treatment-emergent adverse events as assessed by CTCAE.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after single ascending intravenous doses of AON-D21 in healthy male subjects.
Detailed Description
This study will potentially include 5 sequential cohorts with 8 subjects per cohort, then 40 enrolled subjects in total. Within each dose group 6 subjects will be randomized to receive AON-D21 and 2 subjects will be randomly assigned to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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).
- •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.
Arms & Interventions
AON-D21
Single ascending doses by iv infusion.
Intervention: Intravenous AON-D21
Placebo
Placebo medication identical in appearance to active.
Intervention: Intravenous placebo
Outcomes
Primary Outcomes
Primary Safety Endpoint - Per Dosing Cohort number of participants with treatment-emergent adverse events as assessed by CTCAE.
Time Frame: 14 days
Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE per dosing cohort.
Primary Safety Endpoint - Overall number of participants with treatment-emergent adverse events (TEAEs) per dosing cohort as assessed by CTCAE.
Time Frame: 14 days.
To determine the overall safety and tolerability of AON-D21 by analyzing number of participants with treatment-related adverse events as assessed by CTCAE. Nature, occurrence, and severity of treatment-emergent adverse events.
Secondary Outcomes
- Pharmacokinetics of AON-D21.(14 days.)