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NCT00515385 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults
A Phase 1 study of West Nile Virus, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00515385 is a Phase 1 study of West Nile Virus that has completed, run by MacroGenics. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00515385, a Phase 1 study of West Nile Virus, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety, tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single intravenous (IV) infusion to healthy adults. Subjects will be enrolled sequentially into one of 5 dose-level cohorts, with 8 subjects in each cohort. Six subjects in each cohort will receive MGAWN1 (a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus) and 2 will receive a saline control.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG MGAWN1
Study Locations (1)
Maryland
- PAREXEL Phase 1 Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00515385
The ClinicalTrials.gov registry entry for NCT00515385 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MacroGenics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with West Nile Virus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00515385 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00515385 about?
NCT00515385 is a clinical study titled "A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults". The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety, tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single intravenous (IV) infusion to healthy adults. Subjects will be enrolled sequentially into one of 5 dose-level cohorts, w...
What is the current status of trial NCT00515385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-08. Estimated completion is 2009-01.
What conditions does trial NCT00515385 study?
This clinical trial studies the following conditions: West Nile Virus.
What interventions are being tested in trial NCT00515385?
The interventions under investigation include: Placebo (OTHER), MGAWN1 (DRUG).
Who is sponsoring clinical trial NCT00515385?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00515385 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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