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Also known as Bevacizumab
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 therapeutic developed by Viatris Inc. (ticker VTRS). It has been studied in a Phase 1 pharmacokinetic comparability trial in healthy male volunteers. The specific disease indication for MYL-1402O has not been publicly disclosed.
MYL-1402O is developed by Viatris Inc., which trades on Nasdaq under the ticker VTRS. Viatris is the sponsor of the clinical program for MYL-1402O, including the completed Phase 1 pharmacokinetic comparability study conducted in the Netherlands.
MYL-1402O is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. There is no public information indicating that MYL-1402O has received FDA approval, so it remains an investigational drug in clinical development.
MYL-1402O has been evaluated in one completed Phase 1 study, NCT02469987, titled a Phase I Pharmacokinetic Comparability Study in Healthy Male Volunteers. The trial enrolled 111 participants in the Netherlands, was randomized, double blind, and used an active control design.
The MYL-1402O Phase 1 trial NCT02469987 was a randomized, double blind, active controlled pharmacokinetic comparability study. It enrolled 111 healthy male volunteers aged 18 years and older in the Netherlands. The study has been completed, and no biomarker-based patient selection was used.