Trial | NCT02045472  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vis410 ...

  • Study Participants

    41
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.
Study Started
Sep 30
2014
Primary Completion
May 31
2015
Study Completion
May 31
2015
Last Update
May 14
2015
Estimate

Drug VIS410

Drug Placebo

VIS410 Experimental

VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg

Placebo Placebo Comparator

Placebo administered as a single infusion

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
No Results Posted