Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | January 2011 |
| End Date: | October 2011 |
| Contact: | Melinda Roberson |
| Email: | mroberson@snbl-pc.com |
| Phone: | 410-706-8877 |
Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers
The purpose of this study is to determine the safety and tolerability of the anti-TSG101
human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy
volunteers.
human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy
volunteers.
Primary -
- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as
compared with Placebo
Secondary
- To evaluate the pharmacokinetics (PK) of a singel intravenous administration of
FGI-101-1A6
- To evaluate the immunogenicity of FGI-101-1A6
- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as
compared with Placebo
Secondary
- To evaluate the pharmacokinetics (PK) of a singel intravenous administration of
FGI-101-1A6
- To evaluate the immunogenicity of FGI-101-1A6
Inclusion Criteria:
- Healthy volunteers ages 18-45
- Normal laboratory (blood tests) results
Exclusion Criteria:
- Prior immunization with live-attenuated vaccines
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