Anthrax
Conditions
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.
Interventions
DRUGAVP-21D9
intravenously, single dose
DRUGPlacebo
Placebo comparator
Sponsors
National Institutes of Health (NIH)
Emergent BioSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy volunteers, between 18 and 45 years of age * Normal laboratory (blood test) results Key
Exclusion criteria
* Prior immunization with anthrax vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed