Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
amobarbital/One · 1 trial · 2 indications
By using CBC and standard clinical chemistry assays to quantify circulating, ALT, AST, Bilirubin, Creatinine, and BUN and the measurement of urine protein content, the number of participants that have abnormal laboratory values will be determined.
By using osteochondral fragments obtained during the internal fixation surgery, local toxicity will be determined by examining the tissue for cartilage and synovial histological changes.
| Arm | Type | Description |
|---|---|---|
| Phase I single amobarbital/Gel-One dose | EXPERIMENTAL | Phase I: An open label study of 3 patients will be done. If no dose limiting toxic (DLT) side effects occur, then an additional 3 patients will be done. If no DLT events occur, the study will proceed to Phase II. |
| Phase IIa Part 1 amobarbital/Gel-One dose | ACTIVE_COMPARATOR | 20 subjects will be randomized to amobarbital/Gel-One single dose. |
| Phase IIa Part 1 Placebo | PLACEBO_COMPARATOR | 10 subjects will be randomized to amobarbital/Gel-One single dose. |
| Phase IIa Part 2 amobarbital/Gel-One dose | ACTIVE_COMPARATOR | 20 subjects will be randomized to one dose of amobarbital/Gel-One during the initial surgical intervention. A second dose will be administered during the second surgical intervention. |
| Phase IIa Part 2 placebo | PLACEBO_COMPARATOR | 20 subjects will be randomized to one dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention. |
| Name | Type | Description |
|---|---|---|
| amobarbital/Gel-One (one dose) | DRUG | One dose of amobarbital/Gel-One during the initial surgical intervention |
| Placebo (single dose) | DRUG | One dose of placebo during the initial surgical intervention |
| amobarbital/Gel-One (two doses) | DRUG | One dose of amobarbital/Gel-One during the initial surgical intervention. A second dose will be administered during the second surgical intervention. |
| Placebo (two doses) | DRUG | One dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention. |
Inclusion Criteria: * Age 18-60 years * Acute closed or type 1 open ankle fractures (classified as OTA/AO 43 B 1-3 and 43 C 1- 3 or classified as 42 B and C fractures with 25% talar displacement and one of the following; syndesmosis injury or medial malleolar fracture at or above the shoulder) (Mar...
Amobarbital/One is an investigational small molecule being developed for osteoarthritis, including post-traumatic osteoarthritis. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in the context of early interventions to prevent post-traumatic osteoarthritis.
Amobarbital/One is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker symbol UTHR. The company is conducting clinical research on this investigational drug for osteoarthritis.
Amobarbital/One is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 clinical trial has been completed, and the drug remains in early-stage clinical testing for osteoarthritis.
Amobarbital/One has one completed Phase 1 clinical trial, registered as NCT04589611. The trial, titled "Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA," enrolled 5 participants in the United States and studied the drug in osteoarthritis and post-traumatic osteoarthritis.
Amobarbital/One is a distinct drug asset being developed by United Therapeutics Corporation for osteoarthritis. It is a small molecule in Phase 1 clinical trials. No other alternative names for this drug have been disclosed in the available clinical trial information.