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NCT01204866 · ClinicalTrials.gov registry record · Phase 1
Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use
A Phase 1 study of Allergic Reactions, sponsored by PharmAthene.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT01204866 is a Phase 1 study of Allergic Reactions that has completed, run by PharmAthene. The registered enrollment target is 5 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01204866, a Phase 1 study of Allergic Reactions, has completed, sponsored by PharmAthene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously. Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events which were suggestive of allergic or allergic-like reactions. In order to better characterize these reactions and determine if they represent allergic or allergic-like reactions to Valortim or one or more of its components, skin testing of Valortim and selected components on naïve and Valortim-exposed subjects will be performed in this study
Conditions Studied
Interventions
- BIOLOGICAL Valortim and selected Components
- DRUG Valortim and Selected Components
Study Locations (1)
Kansas
- Kansas City Allergy and Asthma - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01204866
The ClinicalTrials.gov registry entry for NCT01204866 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PharmAthene, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Allergic Reactions appearing as the primary indexed condition, and to 2 interventions - of which Valortim and selected Components is the first listed.
NCT01204866 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT01204866 about?
NCT01204866 is a clinical study titled "Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use". The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously. Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events whi...
What is the current status of trial NCT01204866?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-07. Estimated completion is 2010-09.
What conditions does trial NCT01204866 study?
This clinical trial studies the following conditions: Allergic Reactions.
What interventions are being tested in trial NCT01204866?
The interventions under investigation include: Valortim and selected Components (BIOLOGICAL), Valortim and Selected Components (DRUG).
Who is sponsoring clinical trial NCT01204866?
This trial is sponsored by PharmAthene, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01204866 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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