A Study of VIS410 to Assess Safety and Pharmacokinetics

Completed · Phase 1 · Has a placebo group

Conditions studied: Influenza

In brief

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

Key facts

Study ID

NCT02045472

Run by

Visterra, Inc.

People needed

41

Starts

2014-09-01

Expected to finish

2015-05-01

Last updated by the study team

2015-05-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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