A Phase 1 interventional study of AVP-21D9 and Placebo in Anthrax, sponsored by Emergent BioSolutions. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Emergent BioSolutions · Phase 1, Interventional, and Treatment
Primary:
Secondary:
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: AVP-21D9
Drug: Placebo
intravenously, single dose
Placebo comparator
Also known as: Placebo comparator
Safety 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 90 or the early withdrawl visit, if applicable.
Time frame: 90 days following infusion
Pharmacokinetics (PK) analysis
PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9.
Time frame: 90 days following infusion
Immunogenicity analysis
Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation
Time frame: From day 1 up to day 90 following infusion
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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