Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers
Completed
Elusys Therapeutics
Phase 1
2009-02-01
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.
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of
IV doxycycline when administered concomitantly with IV Valortim in normal healthy human
subjects.
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of
IV doxycycline when administered concomitantly with IV Valortim in normal healthy human
subjects.
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of
IV doxycycline when administered concomitantly with IV Valortim in normal healthy human
subjects.
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