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

NCT01202695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-15

No results posted yet for this study

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

Conditions

  • Anthrax

Interventions

DRUG

AVP-21D9

intravenously, single dose

DRUG

Placebo

Placebo comparator

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Robert Hopkins, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202695 on ClinicalTrials.gov