Pharmacokinetics and Safety Study of BI 695501 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

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-01

Study Completion Date

2012-07-01

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.

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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

NONE

Study Groups

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BI 695501

Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501

Group Type EXPERIMENTAL

BI695501

Intervention Type DRUG

BI 695501 single s.c injection

adalimumab - US

Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab

Group Type ACTIVE_COMPARATOR

adalimumab

Intervention Type DRUG

40mg adalimumab single s.c. injection

adalimumab - EU

Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab

Group Type ACTIVE_COMPARATOR

adalimumab

Intervention Type DRUG

40mg adalimumab single s.c. injection

Interventions

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adalimumab

40mg adalimumab single s.c. injection

Intervention Type DRUG

BI695501

BI 695501 single s.c injection

Intervention Type DRUG

adalimumab

40mg adalimumab single s.c. injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy males
2. Body mass index (BMI) =18.5 to =29.9 kg/m2

Exclusion Criteria

1. Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator.
3. Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation.
4. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
5. 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
6. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
7. Inability to refrain from smoking during days of confinement at the study center
8. Alcohol abuse (average more than 30 g/day)
9. Current drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes