Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 695502
* Drug: bevacizumab
* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy males. Complete medical history, including physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests. Aged 21 to 50 years. Body mass index below or equal to 30. Body weight 65 to 95 kg, inclusive. Exclusion criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance. Any evidence of a clinically relevant concomitant disease, as judged by the investigator. History of relevant orthostatic hypotension, fainting spells, or blackouts. Chronic or relevant acute infections. History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients). 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. Participation in another trial with a study medication within two months prior to administration or during the trial (six half-lives). Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day). Inability to refrain from smoking during days of confinement at the study center. Current alcohol abuse as judged by the investigator. Current drug abuse, as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 695502<br>Subject to receive one intravenous (i.v.) infusion of BI 695502 | Drug: BI 695502<br>* BI 695502 single i.v. infusion<br>|
| Active Comparator: bevacizumab A<br>Subject to receive one i.v. infusion of bevacizumab | Drug: bevacizumab<br>* bevacizumab single i.v. infusion<br>|
| Active Comparator: bevacizumab B<br>Subject to receive one i.v. infusion of bevacizumab | Drug: bevacizumab<br>* bevacizumab single i.v. infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞). | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment were made for treatment effect and weight. | Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight. | Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion | 
| Maximum Measured Concentration of the Analyte in Plasma (Cmax) | Maximum measured concentration of the analyte in plasma (Cmax) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight. | Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion. |