A Study of VIS410 to Assess Safety and Pharmacokinetics
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 7/11/2015 |
| Start Date: | September 2014 |
| End Date: | June 2015 |
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.
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
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