Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Healthy
Interventions
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.

Trial Locations (1)

9471 GP

PRA Health Sciences - Early Development Services, Zuidlaren

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mylan GmbH

INDUSTRY

lead

Mylan Inc.

INDUSTRY