Trial | NCT01299142  Report issue

Title

Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
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.
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
Study Started
Jan 31
2011
Primary Completion
Jul 31
2011
Anticipated
Study Completion
Oct 31
2011
Anticipated
Last Update
Feb 18
2011
Estimate

Drug FGI-101-1A6

anti-TSG101 human monoclonal antibody, single dose

FGI-101-1A6 Experimental

Intervention: Drug-FGI-101-1A6

Placebo Placebo Comparator

Intervention: Drug-Placebo

Criteria 

Inclusion Criteria:

Healthy volunteers ages 18-45
Normal laboratory (blood tests) results

Exclusion Criteria:

Prior immunization with live-attenuated vaccines
No Results Posted