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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT01202695
First received: September 13, 2010
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Anthrax
Drug: AVP-21D9
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:
  • Safety assessments [ Time Frame: 90 days following infusion ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 90 days following infusion ] [ Designated as safety issue: No ]
    PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9.

  • Immunogenicity analysis [ Time Frame: From day 1 up to day 90 following infusion ] [ Designated as safety issue: No ]
    Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVP-21D9 Drug: AVP-21D9
intravenously, single dose
Other Name: AVP-21D9
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator
Other Name: Placebo comparator

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202695

Locations
United States, Texas
ICON Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Study Director: Robert Hopkins, M.D. Emergent BioSolutions
  More Information

No publications provided

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01202695     History of Changes
Other Study ID Numbers: EBS.AVP.001, DMID 09-0008
Study First Received: September 13, 2010
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014