drugset / Trial / NCT01204866
Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use
Phase 1
Completed
5 enrolled
PharmAthene, Inc.
National Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institutes of Health (NIH) · collab
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2010-07
- Primary completion
- 2010-08
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MDX-1303 | Monoclonal antibody | 25 mg/ml | Other |
| Subject | Mannitol | Diagnostic / imaging agent | 30 mg/ml | Other |
| Subject | polysorbate 80 | Small molecule | 0.06 mg/ml | Other |
| Subject | polysorbate 80 | Small molecule | 0.2 mg/ml | Other |
| Subject | polysorbate 80 | Small molecule | 0.6 mg/ml | Other |
| Background | Histamine | Small molecule | 1 mg/ml | Other |