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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
48
anti-TSG101 human monoclonal antibody, single dose
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
RECRUITINGSafety assessments
Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 60, or the early withdrawal, if applicable
Time frame: 60 days following infusion
Pharmacokinetic analysis (PK)
PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6
Time frame: 60 days following infusion
Immunogenicity
Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation
Time frame: From day 1 up to day 60 following infusion
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