Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UB-921 · 1 trial · 1 indication
from the baseline to the end of study visit
| Arm | Type | Description |
|---|---|---|
| UB-921 2 mg/kg (Main-study) | EXPERIMENTAL | Intravenous infusion |
| UB-921 6 mg/kg (Main-study) | EXPERIMENTAL | Intravenous infusion |
| UB-921 8 mg/kg (Main-study) | EXPERIMENTAL | Intravenous infusion |
| UB-921 6 mg/kg (Sub-study) | EXPERIMENTAL | Intravenous infusion |
| Herceptin 6 mg/kg (Sub-study) | ACTIVE_COMPARATOR | Intravenous infusion |
| Name | Type | Description |
|---|---|---|
| UB-921 | BIOLOGICAL | 150 mg/vial |
| Herceptin | BIOLOGICAL | 440 mg/vial |
Inclusion Criteria: * Total body weight ≧50 kg (110 lbs) * No clinically relevant abnormalities * To agree on using birth control barrier (eg. male condom) during the entire study period. * Signing the written informed consent form Exclusion Criteria: * Previous exposure to chimeric, humanized or...
UB-921 is a monoclonal antibody being developed by United Therapeutics Corporation for the treatment of breast neoplasm. It is currently in Phase 1 clinical development as an investigational therapy.
UB-921 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy volunteers.
UB-921 is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR.
UB-921 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it is not yet approved by the FDA. The drug remains investigational and is still in clinical development.
UB-921 has one completed clinical trial, NCT03013881, which was a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of UB-921 in healthy volunteers. The trial enrolled 18 participants and was conducted in Taiwan.
UB-921 is not known to have any alternative names. It is a distinct investigational monoclonal antibody being developed by United Therapeutics Corporation.