Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Adalimumab

Criteria

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