Pharmacokinetics and Safety in Healthy Volunteers
Condition: Healthy
Intervention: BI 695501; adalimumab-EU source; adalimumab-US source
Intervention description: BI 695501 single s.c. injection; adalimumab-EU source single s.c. injection; adalimumab-US source single s.c. injection.
Intervention MeSH terms: Adalimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 327.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish
      pharmacokinetic similarity of BI 695501 to adalimumab.
    

Eligibility criteria:

        Inclusion criteria:

        Healthy males according to the following criteria:

          1. Based upon a complete medical history, including the physical examination, vital signs
             (blood pressure [BP] and pulse rate [PR]), 12-lead electrocardiogram (ECG), and
             clinical laboratory tests;

          2. Age-greater than or equal to 18 years and less than or equal to 55 years;

          3. Body mass index (BMI) =18.5 to =29.9 kg/m2; and

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice and the local legislation.

        Exclusion criteria:

          1. Any clinically relevant abnormal finding of the medical examination (including blood
             pressure (BP), pulse rate (PR), and electrocardiogram (ECG) deviating from normal and
             of clinical relevance;

          2. Any evidence of a clinically relevant previous or concomitant disease as judged by the
             investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular,
             metabolic, immunological, hormonal disorders, or diseases of the central nervous
             system (such as epilepsy), psychiatric disorders, or neurological disorders;

          3. History of relevant orthostatic hypotension, fainting spells, or blackouts;

          4. Chronic or relevant acute infections. A negative result for human immunodeficiency
             virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for
             participation;

          5. History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients);

          6. Intake of prescribed or over-the-counter drugs with a long half-life (greater than 24
             hours) within at least one month or at least 5 half-lives of the respective drug
             (whichever is longer) prior to administration or during the trial;

          7. Previous exposure of a biologic drug;

          8. Use of drugs which might reasonably influence the results of the trial prior to dosing
             and at any time during the trial;

          9. Intake of an investigational drug in another trial within two months prior to intake
             of study medication in this trial or intake of an investigational drug during the
             course of this trial;

         10. Smoker (greater than 10 cigarettes or greater than 3 cigars or greater than 3
             pipes/day);

         11. Inability to refrain from smoking during days of confinement at the trial site;

         12. History of alcohol abuse (estimated average more than 4 units/day);

         13. Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours
             prior to the study medication administration and until Day 7 post study medication
             administration;

         14. Unwillingness/inability to limit alcohol intake to a maximum of three units per day
             until e.o.s.;

         15. Current drug abuse;

         16. Blood donation (more than 100 mL within four weeks prior to administration of the
             study medication or during the trial);

         17. Vigorous exercise 72 hours prior to dosing. Unwilling to avoid vigorous exercise for 7
             days post dosing. Contact sport should be avoided during the entire study;

         18. Any out-of-range laboratory values considered clinically significant by the
             investigator; subjects with creatine kinase (CK) values three times the upper limit of
             normal (ULN) at Day -1 are excluded from participation;

         19. Subjects considered unsuitable for inclusion by the investigator (e.g., inability to
             understand and comply with the study requirements or presence of any condition which,
             in the opinion of the investigator, would not allow safe participation in the study);
             or

         20. Inability to comply with dietary regimen of trial site.

         21. Subjects with known Human immunodeficiency virus (HIV), Acquired Immunodeficiency
             Syndrome, other clinically significant immunological disorders, or auto-immune
             disorders, (e.g., Rheumatoid arthritis (RA), lupus erythematosus, scleroderma, etc.);

         22. Subject has received a live or attenuated vaccine within 12 weeks prior to enrolling
             in the trial; or

         23. Positive finding in Interferon-gamma-release assay testing (IGRA-T). In cases where at
             the screening visit the IGRA result is indeterminate, the subject will have a PPD skin
             test performed, provided that the screening period timeframe can be maintained. If
             not, the subject will not be enrolled in this study.