NCT02469987

Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

A Single Center, Randomized, Double-blind, 3-arm Parallel Phase1 Study to Assess PK, Safety, and Tolerability of a Single 90 Min iv Infusion of 1 mg/kg MYL-1402O, EU Avastin®, and US Avastin® in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

Detailed description

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab) in a total of 111 healthy, adult male volunteers (37 subjects per treatment arm). After randomization, subjects will receive one of the following treatments: A single 1 mg/kg dose administered by i.v. infusion (25 mL over approximately 90 minutes) of MYL-1402O, an equivalent i.v. infusion of US marketed Avastin® (1 mg/kg), or an equivalent i.v. infusion of EU marketed Avastin® (1 mg/kg).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MYL-1402O	Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.
DRUG	US marketed Avastin(R)	Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins
DRUG	EU marketed Avastin(R)	Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-06-12
• Last updated: 2022-03-25

Locations

1 site across 1 country: Netherlands