A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 after Single Administration in Healthy Male Japanese Subjects

The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.

This is a Phase I, single centre, randomised, single-blind, placebo-controlled, single ascending dose parallel study in healthy male Japanese subjects. Up to 3 dose levels of MEDI9929 will be investigated. Primary object is to assess the safety and tolerability of single ascending subcutaneous (SC) doses of MEDI9929 in healthy male Japanese subjects. Secondary objectives are to characterize the pharmacokinetics (PK) of MEDI9929 in healthy male Japanese subjects and to evaluate the immunogenicity (IM) of MEDI9929 in healthy male Japanese subjects. Up to 24 healthy subjects aged 20 to 45 years will participate in a maximum of 3 cohorts. Eight subjects will participate in each cohort. Subjects will be randomized in a 3:1 ratio (active: placebo) and will receive a single dose of either MEDI9929 or placebo. Each subject will only participate in one cohort. The first cohort will receive Dose 1 MEDI9929 (n=6) or placebo (n=2), the second cohort will receive Dose 2 MEDI9929 (n=6) or placebo (n=2), and the third cohort will receive Dose 3 MEDI9929 (n=6) or placebo (n=2). Following a screening period of a maximum of 28 days, subjects will stay at the study facility for eight nights starting from the day before dosing (Day –1) to Day 8. The follow up period after the dosing will be 84 days (112 days for cohort 3). Subjects will receive a single dose of MEDI9929 or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period.