This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers. Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection. Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
36
Research Site
Berlin, Germany
Incidence of adverse events
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time frame: From Screening, Day 1 to Day 113
Incidence of abnormal vital signs
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time frame: From Screening, Day 1 to Day 113
Incidence of abnormal laboratory parameters
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Time frame: Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
Time to maximum observed plasma concentration (Tmax) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
Maximum observed plasma concentration (Cmax) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
Pre-dose trough concentration (Ctrough) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
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The volume of plasma cleared of drug per unit time (CL) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Time frame: Day 1 to Day 113
Anti-drug antibodies (ADA)
To characterise the immunogenicity of MEDI0618 administered IV or SC
Time frame: Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113