Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers
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.
Timeline
- Start
- 2009-02
- Primary completion
- 2009-07
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obiltoxaximab | Monoclonal antibody | 120 mg | Intravenous |
| Subject | Obiltoxaximab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Obiltoxaximab | Monoclonal antibody | 360 mg | Intravenous |
Indications
No indication recorded.