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

March 14, 2024 updated by: Emergent BioSolutions

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo comparator
Other Names:
  • Placebo comparator
Experimental: AVP-21D9
Drug: AVP-21D9
intravenously, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days following infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days following infusion
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
From day 1 up to day 90 following infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergent BioSolutions

Collaborators

National Institutes of Health (NIH)

Investigators

  • Study Director: Robert Hopkins, MD, Emergent BioSolutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimated)

September 16, 2010

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBS.AVP.001
  • DMID 09-0008 (Other Grant/Funding Number: HHSN272200800040C)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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