A Study of VIS410 to Assess Safety and Pharmacokinetics

Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VIS410) to Influenza Type A Hemagglutinin

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.

Inclusion Criteria:

• Healthy volunteers
• Body mass index between 18 and 33 kg/m2, inclusive
• Normal labs
• Volunteers agree to use acceptable contraceptive measures

Exclusion Criteria:

• Prior receipt of antibody or biologic therapy
• History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias
• Any chronic condition requiring daily prescription or over the counter medication
• History of a previous severe allergic reaction
• Drug or alcohol abuse within previous 12 months
• Positive serology for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
• Positive pregnancy test
• Breast feeding
• Positive drug or alcohol test at screening or check-in
• Receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration