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Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers

NCT01929226 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2019-04-08

Study results available
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Summary

To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.

Conditions

  • Inhalational Anthrax

Interventions

BIOLOGICAL

ETI-204

Monoclonal Antibody

OTHER

Placebo

Placebo for ETI-204

Sponsors & Collaborators

  • Elusys Therapeutics

    lead OTHER

Principal Investigators

  • Alex King, MD · Covance

  • Lori Sieboldt, MD · Covance Clinical Research - Evansville, IN

  • Debra Mandarino, MD · Covance Research, Madison, WI

  • H. Frank Farmer, PhD, MD · Covance Research - Daytona Beach, Fl

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-09
Primary Completion
2013-11-29
Completion
2013-11-29

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 NCT01929226 on ClinicalTrials.gov