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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: Completed Phase 1 study of Allergic Reactions, sponsored by PharmAthene.
NCT01204866 is a Phase 1 study of Allergic Reactions that has completed, run by PharmAthene. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Assessment of any wheal reaction from the study drug or its selected components and how this compares to the positive and negative control
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 |
What the finished NCT01204866 record still lists
NCT01204866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Allergic Reactions
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01204866's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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