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Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202695
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : November 22, 2012
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Emergent BioSolutions

Brief Summary:


• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo


  • To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
  • To evaluate the immunogenicity of AVP-21D9

Condition or disease Intervention/treatment Phase
Anthrax Drug: AVP-21D9 Drug: Placebo Phase 1

Detailed Description:
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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 Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anthrax

Arm Intervention/treatment
Experimental: AVP-21D9 Drug: AVP-21D9
intravenously, single dose

Placebo Comparator: Placebo Drug: Placebo
Placebo comparator
Other Name: Placebo comparator

Primary Outcome Measures :
  1. Safety assessments [ Time Frame: 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 Outcome Measures :
  1. Pharmacokinetics (PK) analysis [ Time Frame: 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.

  2. Immunogenicity analysis [ Time Frame: From day 1 up to day 90 following infusion ]
    Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01202695

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United States, Texas
ICON Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Emergent BioSolutions
National Institutes of Health (NIH)
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Study Director: Robert Hopkins, M.D. Emergent BioSolutions

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Emergent BioSolutions Identifier: NCT01202695     History of Changes
Other Study ID Numbers: EBS.AVP.001
DMID 09-0008 ( Other Grant/Funding Number: HHSN272200800040C )
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs