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Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers

NCT01932242 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-05-14

Study results available
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Summary

To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of repeat administration (two doses) of intravenous (IV) ETI-204.

Conditions

  • Inhalational Anthrax

Interventions

BIOLOGICAL

ETI-204

Monoclonal Antibody

OTHER

Placebo

Placebo for ETI-204

Sponsors & Collaborators

  • Elusys Therapeutics

    lead OTHER

Principal Investigators

  • David Mathews, MD · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-23
Primary Completion
2014-04-19
Completion
2014-04-19

Countries

  • United States

Study Locations

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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 NCT01932242 on ClinicalTrials.gov