The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
Single Dose IV infusion on Day 1
Single Dose subcutaneous injection on Day 1
Single Dose subcutaneous injection on Day 1
Centre for Clinical Studies, Nucleus Network
Melbourne, Victoria, Australia
Safety and tolerability of ALD403: laboratory variables, ECG and adverse events
* Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events
Time frame: 12 weeks
Evaluation of Pharmacokinetics of ALD403
* Cmax - maximum plasma concentration * Tmax - Time to achieve maximum plasma concentration * AUC - Area under the plasma concentration-time curve * T1/2 - Elimination half-life * Vz - Volume of distribution * CL - Clearance * Bioavailability
Time frame: 12 weeks
Evaluation of pharmacodynamics of ALD403
* Blood perfusion rates * Plasma levels of unbound ALD403 * Immunogenicity
Time frame: 12 weeks
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