Pharmacokinetics and Safety of BI 695501
Condition: Healthy
Intervention: BI695501 Prefilled syringe; BI695501Autoinjector
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after
      single injection using either auto injector or prefilled syringe.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age between 18 and 65 years (inclusive)

          -  BMI of >17.5 to <35.0 kg/m2

          -  Healthy male or female subjects, according to the investigator´s assessment, based on
             a complete medical history including a physical examination, vital signs (blood
             pressure [BP], pulse rate [PR]), 12-lead ECG, and clinical laboratory tests.

          -  Subjects who meet any of the following criteria:

               -  Surgically sterilized (confirmed 6 month prior to enrollment)

               -  Have surgically sterilized sexual partner (confirmed 6 month prior to enrollment)

               -  Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
                  questionable cases a blood sample with simultaneous levels of
                  follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is
                  confirmatory)

          -  Subjects agree to use an adequate contraception, starting from the begin of the trial
             and until 6 months after the dose of the trial drug: e.g. any of the following methods
             plus condom: implants, injectables, combined oral or vaginal contraceptives,
             intrauterine device

          -  Signed and dated written informed consent in accordance with Good Clinical Practice
             (GCP) and local legislation prior to admission to the trial

        Exclusion criteria:

          -  Previous exposure to adalimumab or proposed adalimumab biosimilar drugs.

          -  Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)
             or electrocardiogram (ECG)) that deviates from normal and judged as clinically
             relevant by the investigator.

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular,
             metabolic, immunological, hormonal disorders or diseases of the central nervous system
             (including but not limited to any kind of seizures or stroke), and other relevant
             neurological or psychiatric disorders.

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts.

          -  Chronic or relevant acute infections.

          -  Positive result for HIV, hepatitis B virus (HBV), and hepatitis C (Hep C) at
             screening.

          -  History of relevant allergy or hypersensitivity including allergy to the trial
             medication, its excipients or device materials (e.g. natural rubber or latex).

          -  Within 10 days prior to administration of trial medication, use of drugs that might
             reasonably influence the results of the trial.

          -  Intake of an investigational drug in another trial within 2 months or 5 half-lives
             (whichever longer) prior to planned administration of the trial medication in this
             trial or intake of an investigational drug during the course of this trial.

          -  Alcohol abuse (consumption of more than 28 units/week).

          -  Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours
             prior to the trial medication administration and until Day 14 post trial medication
             administration; and/or to limit alcohol intake to a maximum of 3 units per day until
             e.o.t.

          -  Drug abuse or positive drug screening.

          -  Blood donation of more than 500 mL within 30 days prior to administration of trial
             medication or intended donation during the trial.

          -  Intention to perform excessive physical activities within 4days prior to
             administration of trial medication or contact sport during the entire trial and
             unwilling to avoid vigorous exercise for 14 days post dosing.

          -  Inability to comply with dietary regimen of trial site.

          -  Any out-of-range laboratory values considered clinically significant by the
             investigator; (subjects with creatine kinase (CK) values 2 times the upper limit of
             normal (ULN) at Day -1 are to be excluded from participation).

          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,
             because he is considered not able to understand and comply with trial requirements, or
             has a condition that would not allow safe participation in the trial.

          -  Subjects with any immunological disorders or auto-immune disorders, (e.g., Rheumatoid
             arthritis (RA), lupus erythematosus, scleroderma, etc.).

          -  Subject has received a live vaccine within 12 weeks prior to enrolling in the trial.

          -  History of tuberculosis (TB) or positive finding in Interferon-gamma release assay
             (IGRA).

          -  Evidence of skin irritation or infection at the planned injection place.

          -  Currently enrolled in another investigational device or drug study

          -  Any condition that, in the investigator´s opinion, makes them an unreliable study
             subject or unlikely to complete the trial

          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial