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Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers

NCT01952444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-16

Study results available
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Summary

Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin

Conditions

  • Inhalational Anthrax

Interventions

BIOLOGICAL

ETI-204

A single IV infusion of 16 mg/kg ETI-204 over 90 minutes on Day 1

DRUG

Ciprofloxacin

A single IV Infusion of 400 mg Ciprofloxacin over 60 minutes immediately following the infusion of ETI-204 on Day 1, followed by oral Ciprofloxacin (750 mg every 12 hours) on Days 2-8, and a final oral dose on the morning of Day 9.

Sponsors & Collaborators

  • Elusys Therapeutics

    lead OTHER

Principal Investigators

  • David Mathews, MD · Quintiles, Inc.

  • Jolene Berg, MD · Davita Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-29
Primary Completion
2014-04-09
Completion
2014-04-09

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 NCT01952444 on ClinicalTrials.gov