Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Pharmacokinetics and Safety of BI 695502 in Healthy Subjects: a Randomized, Single-blind, Single-dose, Parallel-arm, Active-comparator Clinical Phase I Study

This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.

Inclusion criteria:

1. Healthy males.
2. Complete medical history, including physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
3. Aged 21 to 50 years.
4. Body mass index below or equal to 30.
5. Body weight 65 to 95 kg, inclusive.

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
2. Any evidence of a clinically relevant concomitant disease, as judged by the investigator.
3. History of relevant orthostatic hypotension, fainting spells, or blackouts.
4. Chronic or relevant acute infections.
5. History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients).
6. Intake of prescribed or over-the-counter drugs within less than 6 half-lives of the respective drug prior to study drug administration or during the trial.
7. Participation in another trial with a study medication within two months prior to administration or during the trial (six half-lives).
8. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day).
9. Inability to refrain from smoking during days of confinement at the study center.
10. Current alcohol abuse as judged by the investigator.
11. Current drug abuse, as judged by the investigator.