Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
- Registration Number
- NCT01202695
- Lead Sponsor
- Emergent BioSolutions
- Brief Summary
Primary:
• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo
Secondary:
* To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
* To evaluate the immunogenicity of AVP-21D9
- Detailed Description
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Healthy volunteers, between 18 and 45 years of age
- Normal laboratory (blood test) results
Key
- Prior immunization with anthrax vaccine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AVP-21D9 AVP-21D9 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety assessments 90 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 90 or the early withdrawl visit, if applicable.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) analysis 90 days following infusion PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9.
Immunogenicity analysis From day 1 up to day 90 following infusion Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation
Trial Locations
- Locations (1)
ICON Development Solutions
🇺🇸San Antonio, Texas, United States