Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 695502; Drug: bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01608087

1302.1

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 3 patient groups

BI 695502

Experimental group

Description:

Subject to receive one intravenous (i.v.) infusion of BI 695502

Treatment:

Drug: BI 695502

bevacizumab A

Active Comparator group

Description:

Subject to receive one i.v. infusion of bevacizumab

Treatment:

Drug: bevacizumab

Drug: bevacizumab

bevacizumab B

Active Comparator group

Description:

Subject to receive one i.v. infusion of bevacizumab

Treatment:

Drug: bevacizumab

Drug: bevacizumab