Approval Probability
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Adjusted LOA
ML Risk
Valortim and selected Components · 1 trial · 1 indication
Assessment of any wheal reaction from the study drug or its selected components and how this compares to the positive and negative control
| Arm | Type | Description |
|---|---|---|
| Stage I | EXPERIMENTAL | Three (3) healthy male or female volunteers aged 18-59 years, not previously exposed to Valortim and who do not have pre-existing allergies |
| Stage II | EXPERIMENTAL | Up to 4 healthy male or female volunteers aged 18-59 previously exposed to intravenous (IV) Valortim in PharmAthene Study #0036-08-05 |
| Name | Type | Description |
|---|---|---|
| Valortim and selected Components | BIOLOGICAL | * Valortim (Lot #10-08-001, 25 mg/mL) will be filtered through a 0.22 µm syringe filter and diluted 1:1000, 1:100, 1:10, and 1:1 in saline. * Polysorbate 80 will be diluted in saline to the following concentrations: 0.06 mg/mL, 0.2 mg/mL, and 0.6 mg/mL. * Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1 * Histamine (1 mg/mL), positive control * Saline (0.9%), negative control |
Inclusion Criteria:Stage I Subjects * In the opinion of the Investigator, subjects should be in generally good health, based upon pre-study medical history and abbreviated physical exam. * Female subjects cannot be pregnant, as confirmed by a negative urine pregnancy test at Study Day 1, prior to s...
Valortim and selected Components is an investigational monoclonal antibody being studied for allergic reactions. It is in Phase 1 clinical development. The drug is being evaluated for percutaneous use, meaning it is applied to the skin. A completed clinical trial enrolled healthy volunteers to assess its safety and tolerability.
Valortim and selected Components is being developed by Altimmune, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALT. The company is conducting clinical research on this monoclonal antibody for the treatment of allergic reactions.
Valortim and selected Components is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its potential use in treating allergic reactions, with one completed Phase 1 trial.
Valortim and selected Components has one completed clinical trial, registered as NCT01204866. The study, titled 'Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use,' was a Phase 1 trial conducted in the United States. It enrolled 5 participants, including healthy volunteers aged 18 years and older.
Yes, Valortim and selected Components is also known as MDX-1303. The clinical trial NCT01204866 refers to the drug as Valortim® (MDX-1303), indicating that MDX-1303 is an alternative name for this monoclonal antibody being developed by Altimmune.