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Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers

NCT00829582 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-11-14

No results posted yet for this study

Summary

Title: Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204 (AnthimTM)

Population: This study will determine the safety, tolerability and pharmacokinetics of a single iv dose of ETI-204 in subjects 18 to 50 years of age. Three cohorts will be studied sequentially: subjects receiving 120 mg, 240 mg and 360 mg of ETI-204. The study will be randomized, double-blind, and stratified by gender. Each cohort will contain 15 subjects (including at least four females), twelve who will receive ETI-204 and three who will receive placebo.

Study Objectives: To determine the safety, tolerability and pharmacokinetics of ETI-204 following a single intravenous administration.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ETI-204, "Anthim"

single intravenous infusion of 120, 240 or 360 mg of ETI-204

OTHER

placebo

single intravenous infusion

Sponsors & Collaborators

  • Elusys Therapeutics

    lead OTHER

Principal Investigators

  • Glen Apseloff, MD · OSU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-07-31
Completion
2009-09-30

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 NCT00829582 on ClinicalTrials.gov