This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
26
Single intravenous administration, at various doses, depending on the cohort
Single intravenous dose
inVentiv Health Clinique
Québec, Canada
Incidence of adverse events, graded by severity
Time frame: Until study discontinuation/termination, up to 120 days
Changes in vital signs during and following MHAB5553A administration
Time frame: Throughout the study, up to 120 days
Changes in physical examination finding during and following MHAB5553A administration
Time frame: Throughout the study, up to 120 days
Changes in clinical laboratory results during and following MHAB5553A administration
Time frame: Throughout the study, up to 120 days
Changes in electrocardiogram (ECG) findings during and following MHAB5553A
Time frame: Throughout the study, up to 120 days
Incidence of serum anti-MHAB5553A antibodies
Time frame: Until study discontinuation/termination, up to 120 days
Maximum serum concentration (Cmax) of MHAB5553A
Time frame: Up to 120 days
Time to Cmax (tmax) of MHAB5553A
Time frame: Up to 120 days
Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A
Time frame: Up to 120 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A
Time frame: Up to 120 days
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Clearance (CL) of MHAB5553A
Time frame: Up to 120 days
Volume of distribution at steady-state (Vss) of MHAB5553A
Time frame: Up to 120 days
Terminal elimination half-life (t1/2) of MHAB5553A
Time frame: Up to 120 days
Mean Residence Time (MRT) of MHAB5553A
Time frame: Up to 120 days