Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

Study Overview
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Brief Summary
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This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.

Official Title
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Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Open-label, Single Dose, Parallel Arm, Active Comparator Clinical Phase I Study

Conditions
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Healthy

Intervention / Treatment
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* Drug: adalimumab
* Drug: BI695501
* Drug: adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy males Body mass index (BMI) =18.5 to =29.9 kg/m2 Exclusion criteria: Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator. Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) Intake of prescribed or over-the-counter drugs with a long half-life (>24 hours) within at least one month or less than 5 half-lives of the respective drug prior to administration or during the trial Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) Inability to refrain from smoking during days of confinement at the study center Alcohol abuse (average more than 30 g/day) Current drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 695501<br>Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501 | Drug: BI695501<br>* BI 695501 single s.c injection<br>|
| Active Comparator: adalimumab - US<br>Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab | Drug: adalimumab<br>* 40mg adalimumab single s.c. injection<br>|
| Active Comparator: adalimumab - EU<br>Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab | Drug: adalimumab<br>* 40mg adalimumab single s.c. injection<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 BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration | 
| Area Under the Concentration-time Curve of the BI 695501 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 BI 695501 in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration | 
| Maximum Measured Concentration of the BI 695501 in Plasma (Cmax) | Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal Half- Life of the BI 695501 in Plasma (t1/2) | Terminal half- life of the BI 695501 in plasma (t1/2). | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration | 
| Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F) | Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F). | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |