Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDX1303 · 1 trial · 1 indication
* Determination of changes from baseline for clinical laboratory tests and urinalysis, body temperature, heart rate, blood pressure, respiratory rate, physical examination and electrocardiogram (ECG). * Occurrence and evaluation of adverse events and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Valortim | ACTIVE_COMPARATOR | Valortim 1mg,5mg,10mg |
| Placebo | PLACEBO_COMPARATOR | Saline solution will be used as the placebo |
| Name | Type | Description |
|---|---|---|
| Normal Saline for Injection | DRUG | Equivalent amounts to subjects weight, once over 120 minutes |
| MDX1303 | BIOLOGICAL | a sterile solution at a protein concentration of 25 mg/mL: 20 mM sodium citrate, 50 mM sodium chloride, 3.0% mannitol, 50 µM diethylenetriamine pentacetic acid and 0.06% polysorbate 80 at pH 6.5. A tubular, clear glass vial, filled with a 5 mL dose of colorless to pale yellow solution. The vial is sealed with a 20 mm stopper and white flip-off seal. |
Inclusion Criteria: 1.Subject must have read, understood, and provided written informed consent 2.Subjects should be in generally good health, based upon pre-study medical history, physical examination, laboratory testing and ECG 3.Laboratory screening values (i.e., hematology, clinical chemistries...
MDX1303 is an investigational monoclonal antibody developed by Altimmune, Inc. (ticker: ALT) for anthrax. It is designed as a treatment for anthrax infection and has been studied in a Phase 1 clinical trial. MDX1303 is also known as Valortim.
MDX1303 is being developed for the treatment of anthrax, an infectious disease caused by Bacillus anthracis. It is intended for use in patients with anthrax infection. The drug is investigational and has not been approved by the FDA.
MDX1303 is developed by Altimmune, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALT. Altimmune is responsible for the clinical development of MDX1303.
MDX1303 is in Phase 1 clinical development. A Phase 1 dose escalation study has been completed. The drug is investigational and has not received FDA approval.
MDX1303 has been evaluated in a Phase 1 clinical trial, NCT01265745, titled 'Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects.' This completed trial enrolled 28 healthy volunteers in the United States.
Yes, MDX1303 is also known as Valortim. Valortim is the brand name used for MDX1303 in its clinical trial, NCT01265745. Both names refer to the same investigational monoclonal antibody developed by Altimmune, Inc.