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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02469987 | Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers | PHASE1 | COMPLETED | 111 | — | — | Apr 1, 2015 | Oct 1, 2015 | Mar 25, 2022 | 1 | Netherlands |
Area under the plasma concentration versus time curve (AUC) for bevacizumab
| Arm | Type | Description |
|---|---|---|
| MYL-1402O | EXPERIMENTAL | MYL-1402O (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes. |
| US Marketed Avastin (R) | ACTIVE_COMPARATOR | US Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes. |
| EU Marketed Avastin(R) | ACTIVE_COMPARATOR | EU Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes. |
| Name | Type | Description |
|---|---|---|
| MYL-1402O | DRUG | Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins. |
| US marketed Avastin(R) | DRUG | Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins |
| EU marketed Avastin(R) | DRUG | Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins. |
Inclusion Criteria: * Males aged 18-55 yrs. (inclusive) * BMI: 19.0 to 30.0 kg/m2 (inclusive) * Weight: ≥ 60kg and ≤100kg * Subjects should be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing. * All intermittent medicat...