Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MYL-1402O · 1 trial · 1 indication
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...
MYL-1402O is an investigational small molecule being developed by Viatris Inc. (ticker: VTRS). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed trial involving 111 participants.
MYL-1402O is being studied for use in healthy volunteers. The completed Phase 1 trial was a pharmacokinetic comparability study in healthy male volunteers, indicating the drug is in early-stage development to assess its pharmacokinetic profile.
MYL-1402O is developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. Viatris is responsible for the clinical development of this investigational small molecule.
MYL-1402O is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
MYL-1402O has one completed clinical trial, NCT02469987, titled 'Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers.' This Phase 1 study enrolled 111 healthy male participants in the Netherlands and was completed.