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
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, see Learn About Clinical Studies.

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 July 31, 2014