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

Sponsor
Emergent BioSolutions (Industry)
Overall Status
Completed
CT.gov ID
NCT01202695
Collaborator
National Institutes of Health (NIH) (NIH)
50
Enrollment
1
Location
2
Arms
10
Duration (Months)
5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
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 :
Aug 1, 2010
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: AVP-21D9

Drug: AVP-21D9
intravenously, single dose
Placebo Comparator: Placebo

Drug: Placebo
Placebo comparator
Other Names:
  • Placebo comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ICON Development Solutions San Antonio Texas United States 78209

    Sponsors and Collaborators

    • Emergent BioSolutions
    • National Institutes of Health (NIH)

    Investigators

    • Study Director: Robert Hopkins, M.D., Emergent BioSolutions

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emergent BioSolutions
    ClinicalTrials.gov Identifier:
    NCT01202695
    Other Study ID Numbers:
    • EBS.AVP.001
    • DMID 09-0008
    First Posted:
    Sep 16, 2010
    Last Update Posted:
    Nov 22, 2012
    Last Verified:
    Nov 1, 2012
    Additional relevant MeSH terms:
    Anthrax

    Study Results

    No Results Posted as of Nov 22, 2012