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Completed

NCT Number: NCT01202695

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

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

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Key information

Conditions

Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Development Solutions

San Antonio, Texas, 78209, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVP-21D9

Drug

intravenously, single dose

Placebo

Drug

Placebo comparator

Other names: Placebo comparator

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2010
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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