Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
NCT ID: NCT01202695
Last Updated: 2024-03-15
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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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2010-08-31
2011-06-30
Brief Summary
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• 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AVP-21D9
AVP-21D9
intravenously, single dose
Placebo
Placebo
Placebo comparator
Interventions
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AVP-21D9
intravenously, single dose
Placebo
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal laboratory (blood test) results
Exclusion Criteria
18 Years
45 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Emergent BioSolutions
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Hopkins, MD
Role: STUDY_DIRECTOR
Emergent BioSolutions
Locations
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ICON Development Solutions
San Antonio, Texas, United States
Countries
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References
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Malkevich NV, Hopkins RJ, Bernton E, Meister GT, Vela EM, Atiee G, Johnson V, Nabors GS, Aimes RT, Ionin B, Skiadopoulos MH. Efficacy and safety of AVP-21D9, an anthrax monoclonal antibody, in animal models and humans. Antimicrob Agents Chemother. 2014 Jul;58(7):3618-25. doi: 10.1128/AAC.02295-13. Epub 2014 Apr 14.
Other Identifiers
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DMID 09-0008
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EBS.AVP.001
Identifier Type: -
Identifier Source: org_study_id
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