Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers

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.

Inclusion Criteria:Healthy men and women of non-child bearing potentialAged 18 to 50 years, inclusiveWeigh more than 50 kgBody Mass Index between 18 to 30 kg/m2Healthy, in the opinion of the Principal InvestigatorAble to understand and comply with the protocol requirementsExclusion Criteria:Participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longerDonation of blood or plasma within 2 months prior to screening and until after the final follow-up visitPoor venous accessHistory of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologicsPrescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or disorderHistory of cancer within 5 years of screeningHistory of drug abuseUse of prescriptions or non-prescription medicines within 7 days or 5 half-lives, whichever is longer, prior to administration of study treatmentsAny clinical abnormality on complete physical examination, vitals signs, ECG or clinical laboratory test results at screening or between screening and randomisation