Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
NCT ID: NCT01299142
Last Updated: 2011-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2011-01-31
2011-10-31
Brief Summary
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Detailed Description
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\- 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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FGI-101-1A6
Intervention: Drug-FGI-101-1A6
FGI-101-1A6
anti-TSG101 human monoclonal antibody, single dose
Placebo
Intervention: Drug-Placebo
FGI-101-1A6
anti-TSG101 human monoclonal antibody, single dose
Interventions
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FGI-101-1A6
anti-TSG101 human monoclonal antibody, single dose
Eligibility Criteria
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Inclusion Criteria
* Normal laboratory (blood tests) results
Exclusion Criteria
18 Years
45 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Functional Genetics Inc.
INDUSTRY
Responsible Party
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Functional Genetics
Locations
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SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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W911NF-11-C-0029
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FGI-101-CP002
Identifier Type: -
Identifier Source: org_study_id
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