Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03013881 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers | PHASE1 | COMPLETED | 18 | — | — | Mar 5, 2018 | Apr 2, 2019 | Apr 3, 2019 | 1 | Taiwan |
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...