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.

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. - MYL-1402O equivalency study to EU and US marketed Avastin.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42579

Enrollment

111

Registered

2015-03-05

Start date

2015-03-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

A single dose of 1 milligram per kilogram bodyweight MYL 1402O or 1 mg/kg of one of the two registered Avastin® formulations as a 25 milliliter (mL) intravenous infusion of 90 minutes.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To investigate the comparability of the pharmacokinetics (PK) of Mylan*s MYL 1402O solution for intravenous (i.v.) infusion versus the US and EU marketed versions of Avastin® as well as comparing the US approved Avastin® to EU approved Avastin® following a single 1 mg/kg i.v. infusion over 90 minutes in healthy adult male volunteers.	—

Secondary

Measure	Time frame
To compare the safety, tolerability, and immunogenicity of Mylan*s MYL-1402O with those of US and EU approved Avastin® following a single 1 mg/kg i.v. infusion over 90 minutes in healthy adult male volunteers.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)