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.
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 receive AON-D21 and 2 subjects will be randomly assigned to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Nuvisan GmbH
Neu-Ulm, Germany
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Nature, occurrence, and severity of treatment-emergent adverse events.
Time frame: 27 days
Per dosing cohort number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.
Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 per dosing cohort.
Time frame: 27 days
Pharmacokinetics assessment
Area under the concentration-time curve (AUC) over the dosing interval at steady state (AUC0-tau) of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Maximum concentration at steady state (Cmax) of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Average drug concentration at steady state (Cav) of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Trough concentrations (Ctrough) of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Time of maximum concentration at steady state (Tmax) of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Terminal half-life at steady state (t1/2) of AON-D21 in plasma.
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Time frame: 27 days
Pharmacokinetics assessment
Accumulation ratios for Cmax and AUC of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Clearance (CL) of AON-D21 in plasma at steady state.
Time frame: 27 days
Pharmacokinetics assessment
Volume of distribution (Vz) of AON-D21 in plasma at steady state.
Time frame: 27 days
Pharmacokinetics assessment
AUC from 0 to 48 hours (AUC0-48) after the first dose of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
AUC from 0 extrapolated to infinity (AUC0-inf) after the first dose of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Maximum concentration (Cmax) after the first dose of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Time to maximum concentration (Tmax) after the first dose of AON-D21 in plasma.
Time frame: 27 days
Pharmacokinetics assessment
Terminal half life (t1/2) after the first dose of AON-D21 in plasma.
Time frame: 27 days
Pharmacodynamics assessment
Measurement of concentration of C5 in plasma.
Time frame: 27 days
Pharmacodynamics assessment
Measurement of concentration of C5a in plasma.
Time frame: 27 days
Pharmacodynamics assessment
Measurement of concentration of C5b-9 in plasma.
Time frame: 27 days
Pharmacodynamics assessment
Qualitative assessment of terminal complement complex (TCC) formation in plasma.
Time frame: 27 days
To assess potential for immunogenicity
Measurement of anti-drug antibodies (ADA) in plasma.
Time frame: 27 days
To assess potential for immunogenicity
Measurement of anti-polyethylene glycol (PEG) antibodies in plasma.
Time frame: 27 days