A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to
evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when
administered to healthy adult subjects. Approximately 136 subjects will be entered to
receive treatment across 5 fixed dose cohorts at 1 site. Investigational product will be
delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. A total of
4 different dose levels of investigational product will be evaluated across the 5 cohorts.
Subjects will be followed for approximately 1 year.

Key Inclusion Criteria:

- Age 18 through 49 years and in good health by history, physical exam, and labs

- Weight ≥ 45 kg and ≤ 110 kg at screening

- Written informed consent prior to performing any protocol related procedures,
including screening evaluations

- Ability to complete the follow-up period of 360 days

Key Exclusion Criteria:

- Acute illness including fever ≥ 99.5°F on day of dosing

- Any drug therapy within 7 days prior to Day 1 (except contraceptives)

- Receipt of any investigational drug therapy within 120 days prior to investigational
product dosing through 360 days after investigational product dosing

- Previous receipt of a monoclonal antibody (mAb)

- Pregnant or nursing mother

- Concurrent enrollment in another interventional study