Back to resultsSafety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Primary Purpose
Anthrax
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AVP-21D9
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anthrax
Eligibility 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
Sites / Locations
- ICON Development Solutions
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AVP-21D9
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetics (PK) analysis
PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9.
Immunogenicity analysis
Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation
Full Information
NCT ID
NCT01202695
First Posted
September 13, 2010
Last Updated
November 20, 2012
Sponsor
Emergent BioSolutions
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT01202695
Brief Title
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Official Title
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergent BioSolutions
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthrax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AVP-21D9
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AVP-21D9
Intervention Description
intravenously, single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo comparator
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Safety assessments
Description
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
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) analysis
Description
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
Title
Immunogenicity analysis
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hopkins, M.D.
Organizational Affiliation
Emergent BioSolutions
Official's Role
Study Director
Facility Information:
Facility Name
ICON Development Solutions
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24733473
Citation
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.
Results Reference
derived
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Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
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