Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI695501; Drug: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505491

1297.1

Details and patient eligibility

About

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

Enrollment: 193 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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193 participants in 3 patient groups

BI 695501

Experimental group

Description:

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

Treatment:

Drug: BI695501

adalimumab - US

Active Comparator group

Description:

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

Treatment:

Drug: adalimumab

Drug: adalimumab

adalimumab - EU

Active Comparator group

Description:

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

Treatment:

Drug: adalimumab

Drug: adalimumab