A single center, randomized, double-blind, 3-arm parallel Phase I study to assess pharmacokinetics, safety and tolerability of MYL-1402O solution for intravenous infusion after 90 minute intravenous infusion at one dose level (equivalent weight-adjusted dose (1 mg/kg) compared to the EU and US marketed drug product (Avastin®) in healthy male volunteers.
Completed
- Conditions
- Cancer10035227
- Registration Number
- NL-OMON42579
- Lead Sponsor
- Mylan Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 111
Inclusion Criteria
Healthy male volunteers
18 - 55 years, inclusive
60 - 100 kilograms, inclusive
BMI 19.0 - 30.0 kilograms/meter2
Non smokers or Light smokers
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the comparability of the pharmacokinetics (PK) of Mylan*s MYL<br /><br>1402O solution for intravenous (i.v.) infusion versus the US and EU marketed<br /><br>versions of Avastin® as well as comparing the US approved Avastin® to EU<br /><br>approved Avastin® following a single 1 mg/kg i.v. infusion over 90 minutes in<br /><br>healthy adult male volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare the safety, tolerability, and immunogenicity of Mylan*s MYL-1402O<br /><br>with those of US and EU approved Avastin® following a single 1 mg/kg i.v.<br /><br>infusion over 90 minutes in healthy adult male volunteers.</p><br>