A Study of VIS410 to Assess Safety and Pharmacokinetics

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Visterra, Inc.
• Treatments: Antibodies, Monoclonal

Criteria

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