Status:
COMPLETED
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Lead Sponsor:
Emergent BioSolutions
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Anthrax
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 admin...
Detailed Description
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.
Eligibility Criteria
Inclusion
- Key
- Healthy volunteers, between 18 and 45 years of age
- Normal laboratory (blood test) results
- Key
Exclusion
- Prior immunization with anthrax vaccine
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01202695
Start Date
August 1 2010
End Date
June 1 2011
Last Update
March 15 2024
Active Locations (1)
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1
ICON Development Solutions
San Antonio, Texas, United States, 78209