This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
38
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Maximum plasma concentration (Cmax) of CSL312 after subcutaneous dosing
Time frame: Up to 85 days postdose
Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf) of CSL312 after subcutaneous dosing
Time frame: Up to 85 days postdose
Time to maximum concentration (Tmax) of CSL312 after subcutaneous dosing
Time frame: Up to 85 days postdose
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL312 after subcutaneous dosing
Time frame: Up to 85 days postdose
Half-life (t1/2) of CSL312 after subcutaneous dosing
Time frame: Up to 85 days postdose
Apparent clearance (CL/F) of CSL312 after subcutaneous dosing
Time frame: Up to 85 days postdose
Apparent volume of distribution (Vz/F) of CSL312 after subcutaneous dosing
Time frame: Up to 85 days postdose
Cmax of CSL312 after intravenous dosing
Time frame: Up to 85 days postdose
Tmax of CSL312 after intravenous dosing
Time frame: Up to 85 days postdose
AUC0-last of CSL312 after intravenous dosing
Time frame: Up to 85 days postdose
AUC0-inf of CSL312 after intravenous dosing
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Time frame: Up to 85 days postdose
t1/2 of CSL312 after intravenous dosing
Time frame: Up to 85 days postdose
Clearance (CL) of CSL312 after intravenous dosing
Time frame: Up to 85 days postdose
Volume of distribution (Vd) of CSL312 after intravenous dosing
Time frame: Up to 85 days postdose
Mean FXIIa-mediated kallikrein activity
Time frame: Up to 85 days postdose
Number of subjects experiencing adverse events (AEs)
Time frame: Up to 85 days postdose
Percentage of subjects experiencing AEs
Time frame: Up to 85 days postdose
Number of subjects experiencing serious adverse events (SAEs)
Time frame: Up to 85 days postdose
Percentage of subjects experiencing SAEs
Time frame: Up to 85 days postdose
Number of subjects experiencing adverse events of special interest (AESIs)
Time frame: Up to 85 days postdose
Percentage of subjects experiencing AESIs
Time frame: Up to 85 days postdose
Number of subjects experiencing Anti-CSL312 antibodies
Time frame: Up to 85 days postdose
Percentage of subjects experiencing Anti-CSL312 antibodies
Time frame: Up to 85 days postdose
Number of subjects with injection / infusion site reaction by severity
Time frame: Up to 48 hours after start of infusion or injection
Percentage of subjects with injection / infusion site reaction by severity
Time frame: Up to 48 hours after start of infusion or injection