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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: Completed Phase 1 study of West Nile Virus, sponsored by MacroGenics.
NCT00515385 is a Phase 1 study of West Nile Virus that has completed, run by MacroGenics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00515385 record still lists
NCT00515385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00515385's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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