| Outcome Measures: |
Primary: Number of subjects with adverse events (AEs) and serious adverse events (SAEs), To assess AEs as a variable of safety and tolerability of SC of MEDI8367, From screening (Day -28) to follow-up period (Day 90 ± 4 days)|Number of subjects with abnormal systolic blood pressure (SBP), To assess supine position SBP as a variable of safety and tolerability of MEDI8367, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of patients with abnormal diastolic blood pressure (DBP), To assess supine position DBP as a variable of safety and tolerability of MEDI8367, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of subjects with abnormal HR, To assess change in supine position HR as a variable of safety and tolerability of MEDI8367, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of subjects with respiratory rate, To assess change in supine position respiratory rate as a variable of safety and tolerability of MEDI8367, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of subjects with abnormal oral body temperature, To assess change in oral body temperature as a variable of safety and tolerability of MEDI8367, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of subjects with abnormal electrocardiogram (ECG), To assess electrical activity changes in ECG as a variable of safety and tolerability of MEDI8367, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of subjects with abnormal physical examination, To assess change in physical examination as a variable of safety and tolerability of MEDI8367, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of subjects with abnormal structured neurological assessment, To assess change in structured neurological assessment as safety and tolerability of MEDI8367. Any new or aggravated clinically relevant abnormal neurological examination finding compared to the baseline assessment will be reported as an AE, From screening (Day -28 ) up to follow-up period (Day 90 ± 4 days)|Number of subjets with abnormal retinal imaging, To assess retinal imaging as a variable of safety and tolerability of MEDI8367. The presence of proliferative retinopathy or any other new retinal changes will be recorded. Any new or aggravated clinically relevant abnormal retinal imaging finding compared to the baseline assessment will be reported as an AE, From screening (Day -28) up to follow-up period (Day 90 ± 4 days)|Number of subjects with abnormal Hemoglobin (Hb) level, To assess change in Hb as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal red blood cells (RBC) count, To assess RBC count as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal white blood cells (WBC) count, To assess WBC count as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal differential WBC count, To assess differential WBC count as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal hematocrit (HCT), To assess HCT as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal mean corpuscular volume (MCV), To assess MCV as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal mean corpuscular hemoglobin (MCH), To assess MCH as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal reticulocytes absolute count, To assess reticulocytes absolute count as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal mean corpuscular hemoglobin concentration (MCHC), To assess MCHC as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal platelets count, To assess platelets count as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal creatinine level, To assess creatinine level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal blood urea nitrogen level, To assess blood urea nitrogen level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urea level., To asses urea level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal bicarbonate level, To asses bicarbonate level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal creatine kinase (CK) level, To asses CK level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal follicle stimulating hormone (FSH)/luteinizing hormone (LH) level, To asses FSH/LH level for postmenopausal females as a variable of safety and tolerability of MEDI8367, From screening (Day -28) to treatment period (Day -1)|Number of subjects with abnormal C-reactive protein (CRP) level, To asses CRP level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal cystatin C level, To asses cystatin C level in Cohort 6 only (subjects with CKD) as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal glucose (fasting) level, To asses glucose (fasting) level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal potassium level, To assess potassium level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal sodium level, To assess sodium level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal phosphate level, To assess phosphate level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal calcium level, To assess calcium level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal chloride level, To assess chloride level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal alkaline phosphatase (ALP), To assess ALP level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal bilirubin level, To assess bilirubin level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal alanine aminotransferase (ALT), To assess ALT as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal aspartate aminotransferase (AST), To assess AST as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal albumin level, To assess albumin level as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine protein level, To assess change in urine protein as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine glucose level, To assess changes in abnormal urine glucose as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine pH, To assess change in urine pH as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine ketone level, To assess change in urine ketone as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine bilirubin level, To assess change in urine bilirubin as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine blood level, To assess change in urine blood as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine color., To assess change in urine color as a variable of safety and tolerability of MEDI8367 following SC administration of SAD., From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine appearance., To assess change in urine apperance as a variable of safety and tolerability of MEDI8367 following SC administration of SAD., From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine specific gravity level, To assess change in urine specific gravity as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine leukocyte esterase level, To assess change in urine leukocyte esterase as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine urobilinogen level, To assess change in urine urobilinogen as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine nitrite level, To assess change in urine nitrite as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine RBC level, To assess change in urine microscopy included RBC as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine WBC level, To assess change in urine microscopy included WBC as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days)|Number of subjects with abnormal urine casts level, To assess change in urine microscopy casts as a variable of safety and tolerability of MEDI8367, From screening (Day -28 to Day -2) through follow-up period (up to Day 90 ± 4 days) | Secondary: Plasma PK analysis: Maximum observed serum drug concentration (Cmax), To assess Cmax of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Time to reach maximum observed concentration (tmax), To assess tmax of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Terminal half-life (t½), To assess t½ of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast), To assess AUClast of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Area under plasma concentration-time curve from zero to infinity (AUCinf), To assess AUCinf of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Apparent total body clearance of drug from serum after extravascular administration (CL/F), To assess CL/F of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Volume of distribution (apparent) following extravascular administration (based on terminal phase; Vz/F), To assess Vz/F of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Volume of distribution (apparent) at steady state following extravascular administration (Vss/F), To assess Vss/F of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Area under plasma concentration-time curve from zero to the last quantifiable concentration divided by the dose administered (AUClast/D), To assess AUClast/D of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Area under plasma concentration-time curve from zero to infinity divided by the dose administered (AUCinf/D), To assess AUCinf/D of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Plasma PK analysis: Maximum observed serum drug concentration divided by the dose administered (Cmax/D)., To assess Cmax/D of MEDI8367 following SC administration of SAD., From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Immunogenecity: ADA titer, To assess ADA titer of MEDI8367 following SC administration of SAD, From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)|Immunogenecity: Anti-drug antibody (ADA) incidence., To assess ADA incidence of MEDI8367 following SC administration of SAD., From treatment period (Day 1) to follow-up period (up to Day 90 ± 4 days)
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