Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Protexia · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 50 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
| 2 | EXPERIMENTAL | Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 100 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
| 3 | EXPERIMENTAL | Eight volunteers total. Randomized such that six volunteers will receive Protexia as a single 250 mg dose and two volunteers will receive saline placebo of the same volume on Study Days 1 and 72. Volunteers to be followed for approximately 142 days total. |
| 4 | EXPERIMENTAL | Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 500 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
| 5 | EXPERIMENTAL | Six volunteers total. Randomized such that four volunteers will receive Protexia as a single 750 mg dose and two volunteers will receive saline placebo of the same volume on Study Day 1. Volunteers to be followed for approximately 71 days total. |
| Name | Type | Description |
|---|---|---|
| Protexia | BIOLOGICAL | Single 50 mg IM dose |
Inclusion Criteria: * Healthy male or female volunteers aged 18 to 55 years * Willing to give written informed consent to participate in the study and to comply with all study requirements and procedures * In the opinion of the Investigator, in generally good health, based upon pre-study medical hi...
Protexia is an investigational monoclonal antibody being developed as an intervention for nerve agent exposure. It is intended for use in individuals exposed to nerve agents, which are toxic chemical compounds that can cause severe harm. The drug is currently in clinical development and has not been approved by regulatory authorities.
Protexia is being developed by Altimmune, Inc., a biopharmaceutical company. Altimmune's stock is traded under the ticker symbol ALT. The company is conducting clinical research on Protexia as a potential medical countermeasure for nerve agent exposure.
Protexia is in Phase 1 clinical development. A Phase 1 trial has been completed, which was a first-time-in-human study. The drug remains investigational and is still undergoing clinical evaluation. It has not received regulatory approval and is not yet available for commercial use.
Protexia has one completed Phase 1 clinical trial with the identifier NCT00744146, titled 'First Time in Human Study of Protexia.' The trial enrolled 33 participants in the United States and included healthy volunteers. The study was randomized, double-blind, and controlled, with participants aged 18 years and older.
Yes, Protexia is a monoclonal antibody. It is being developed as a potential intervention for nerve agent exposure. Monoclonal antibodies are laboratory-made proteins that can bind to specific targets in the body. Protexia is currently in Phase 1 clinical development and remains investigational.