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Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers

NCT01453907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-11-14

No results posted yet for this study

Summary

This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to 65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study will be randomized, double-blind and stratified by gender. Each cohort will contain 36 subjects (including at least four females), 30 who will receive ETI-204 and six who will receive placebo.

Conditions

  • Anthrax

Interventions

DRUG

ETI-204, "Anthim"

intravenously, single dose

DRUG

placebo

intravenously, single dose

Sponsors & Collaborators

  • Elusys Therapeutics

    lead OTHER

Principal Investigators

  • Eleanor A Lisbon, M.D., M.P.H · Quintiles Phase One Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-06-30
Completion
2012-12-31

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 NCT01453907 on ClinicalTrials.gov