Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-528 administered to healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
MEDI-528 (1 mg/kg) administered as a single, IV dose
MEDI-528 (3 mg/kg) administered as a single, IV dose
MDS Pharma Services
New Orleans, Louisiana, United States
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time frame: Days 0 - 84
Incidence of Abnormal Troponin Levels
Number of participants with troponin levels greater than upper limit of normal (\> 0.05 ng/mL)
Time frame: Days 0, 7, 14, 21, and 28
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Time frame: Days 0 - 84
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants who had ADA detected at each time point
Time frame: Days 14, 28, 42, and 84
Time to Observed Maximum Serum Concentration (Tmax)
Tmax of MEDI-528
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Observed Maximum Serum Concentration (Cmax)
Cmax of MEDI-528
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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MEDI-528 (9 mg/kg) administered as a single, IV dose
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528
Time frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Total Body Clearance (CL)
CL of MEDI-528
Time frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Half-life (T1/2)
T1/2 of MEDI-528
Time frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
Terminal Phase Elimination Rate (Vz)
Vz of MEDI-528
Time frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84