Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-01

Study Completion Date

2012-11-01

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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BI 695502

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

Group Type EXPERIMENTAL

BI 695502

Intervention Type DRUG

BI 695502 single i.v. infusion

bevacizumab A

Subject to receive one i.v. infusion of bevacizumab

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

bevacizumab single i.v. infusion

bevacizumab B

Subject to receive one i.v. infusion of bevacizumab

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

bevacizumab single i.v. infusion

Interventions

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BI 695502

BI 695502 single i.v. infusion

Intervention Type DRUG

bevacizumab

bevacizumab single i.v. infusion

Intervention Type DRUG

bevacizumab

bevacizumab single i.v. infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes