Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
- Registration Number
- NCT01299142
- Lead Sponsor
- Functional Genetics Inc.
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- Healthy volunteers ages 18-45
- Normal laboratory (blood tests) results
- Prior immunization with live-attenuated vaccines
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo FGI-101-1A6 Intervention: Drug-Placebo FGI-101-1A6 FGI-101-1A6 Intervention: Drug-FGI-101-1A6
- Primary Outcome Measures
Name Time Method Safety assessments 60 days following infusion 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
- Secondary Outcome Measures
Name Time Method Pharmacokinetic analysis (PK) 60 days following infusion PK parameters will be determined for a single administration of FGI-101-1A6 as measured by an immunoassay for FGI-101-1A6
Immunogenicity From day 1 up to day 60 following infusion Immunogenicity will be measured by testing serum on anti-FGI-101-1A6 generation
Trial Locations
- Locations (1)
SNBL Clinical Pharmacology Center
🇺🇸Baltimore, Maryland, United States