Healthy
Conditions
Brief summary
Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.
Interventions
DRUGBI 695501
BI 695501 single s.c. injection
adalimumab-EU source single s.c. injection
DRUGadalimumab-US source
adalimumab-US source single s.c. injection.
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing. | Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®. Abbreviation used: Pharmacokinetics (PK). |
| Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing. | Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®. |
| Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing. | Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing | Area under the concentration time curve (AUC) from time zero to 648 hours post dose (AUC 0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s). |
| AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing | Area under the concentration time curve (AUC) from time zero to 1032 hours post dose (AUC 0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® PK is the abbreviation for Pharmacokinetic(s). |
| AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing | Area under the concentration time curve (AUC) from time zero to 168 hours post dose (AUC 0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s). |
| Number (Proportion) of Subjects With Drug Related Adverse Events | Day 1 through Day 71 | All events with an onset after the first administration of the trial medication up to a period of 70 days after the last administration of the trial medication (i.e., end of the REP) was assigned to the treatment phase for evaluation and was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication. All safety data were displayed and analyzed using descriptive statistical methods. No formal inferential analyses were planned for safety comparisons. Tabulations of frequencies and proportions, as appropriate were used for the evaluation of categorical (qualitative) data, and tabulations of descriptive statistics were used to analyze continuous (quantitative) data. |
| AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing. | Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) based on the last observed concentration at time of last measureable concentration (tz) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation of Pharmacokinetic(s). |
| AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing | Area under the concentration time curve (AUC) from time zero to 312 hours post dose (AUC 0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s). |
| AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira® | at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing | Area under the concentration time curve (AUC) from time zero to 480 hours post dose (AUC 0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s). |
Countries
Belgium, New Zealand
Participant flow
Recruitment details
In this trial 324 healthy subjects were randomized into 3 arms.
Pre-assignment details
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not randomised to trial treatment if any one of the specific entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| BI 695501 single s.c. injection 40 mg/0.8 mL BI 695501 solution. | 108 |
| US-licensed Humira® single s.c. injection 40 mg/0.8 mL US-licensed Humira® | 108 |
| EU-approved Humira® single s.c. injection 40 mg/0.8 mL EU-approved Humira® | 108 |
| Total | 324 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Informed Consent Withdrawn | 2 | 0 | 1 |
| Overall Study | not specified above | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | BI 695501 | US-licensed Humira® | EU-approved Humira® | Total |
|---|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 11 | 31 years STANDARD_DEVIATION 11 | 30 years STANDARD_DEVIATION 12 | 31 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 108 Participants | 108 Participants | 108 Participants | 324 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 108 | 52 / 108 | 51 / 108 |
| serious Total, serious adverse events | 3 / 108 | 3 / 108 | 2 / 108 |
Outcome results
Primary
Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®. Abbreviation used: Pharmacokinetics (PK).
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Population: PK analysis set consisted of all randomized subjects who received the single dose of trial medication (BI 695501, US-licensed - or EU-approved Humira®), had at least one evaluable primary PK endpoint and were without important protocol deviations or violations thought to significantly affect the PK of BI 695501, US-licensed - or EU-approved Humira®
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2630 microgram (µg)*hour (h)/millilitre (mL) | Geometric Coefficient of Variation 52.4 |
| US-licensed Humira® | Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2470 microgram (µg)*hour (h)/millilitre (mL) | Geometric Coefficient of Variation 51.2 |
| EU-approved Humira® | Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2650 microgram (µg)*hour (h)/millilitre (mL) | Geometric Coefficient of Variation 38.5 |
90% CI: [98.5, 119.79]
90% CI: [92.45, 110.94]
90% CI: [86.01, 102.78]
Primary
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2440 µg*h/mL | Geometric Coefficient of Variation 47.8 |
| US-licensed Humira® | Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2300 µg*h/mL | Geometric Coefficient of Variation 45.1 |
| EU-approved Humira® | Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2480 µg*h/mL | Geometric Coefficient of Variation 33.5 |
90% CI: [98.49, 116.94]
90% CI: [92.15, 108.37]
90% CI: [86.76, 101.11]
Primary
Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®
Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira® | 3.907 µg/mL | Geometric Coefficient of Variation 34.1 |
| US-licensed Humira® | Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira® | 3.900 µg/mL | Geometric Coefficient of Variation 34.5 |
| EU-approved Humira® | Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira® | 4.140 µg/mL | Geometric Coefficient of Variation 30.4 |
90% CI: [95.15, 106.88]
90% CI: [91.06, 102.03]
90% CI: [90.83, 101.33]
Secondary
AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 1032 hours post dose (AUC 0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® PK is the abbreviation for Pharmacokinetic(s).
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2190 µg*h/mL | Geometric Coefficient of Variation 41.4 |
| US-licensed Humira® | AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2080 µg*h/mL | Geometric Coefficient of Variation 38.5 |
| EU-approved Humira® | AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® | 2210 µg*h/mL | Geometric Coefficient of Variation 29.1 |
90% CI: [99.07, 114.63]
90% CI: [94.24, 108.12]
90% CI: [89.53, 101.6]
Secondary
AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 168 hours post dose (AUC 0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s).
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira® | 480 µg*h/mL | Geometric Coefficient of Variation 41.1 |
| US-licensed Humira® | AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira® | 493 µg*h/mL | Geometric Coefficient of Variation 40.7 |
| EU-approved Humira® | AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira® | 513 µg*h/mL | Geometric Coefficient of Variation 39.9 |
90% CI: [91.54, 105.55]
90% CI: [89.27, 103.36]
90% CI: [91.42, 105.27]
Secondary
AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 312 hours post dose (AUC 0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s).
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira® | 957 µg*h/mL | Geometric Coefficient of Variation 36.5 |
| US-licensed Humira® | AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira® | 967 µg*h/mL | Geometric Coefficient of Variation 34.9 |
| EU-approved Humira® | AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira® | 1010 µg*h/mL | Geometric Coefficient of Variation 31.6 |
90% CI: [93.66, 105.94]
90% CI: [91.39, 103.35]
90% CI: [92.58, 103.68]
Secondary
AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 480 hours post dose (AUC 0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s).
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira® | 1400 µg*h/mL | Geometric Coefficient of Variation 35.8 |
| US-licensed Humira® | AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira® | 1390 µg*h/mL | Geometric Coefficient of Variation 32.2 |
| EU-approved Humira® | AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira® | 1440 µg*h/mL | Geometric Coefficient of Variation 28 |
90% CI: [95.45, 107.36]
90% CI: [93.27, 104.72]
90% CI: [93.15, 103.11]
Secondary
AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 648 hours post dose (AUC 0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation for Pharmacokinetic(s).
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira® | 1730 µg*h/mL | Geometric Coefficient of Variation 37 |
| US-licensed Humira® | AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira® | 1680 µg*h/mL | Geometric Coefficient of Variation 33.2 |
| EU-approved Humira® | AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira® | 1760 µg*h/mL | Geometric Coefficient of Variation 27.2 |
90% CI: [97.47, 110.29]
90% CI: [94.37, 106.29]
90% CI: [92.07, 102.24]
Secondary
AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) based on the last observed concentration at time of last measureable concentration (tz) of BI 695501, US-licensed Humira® or EU-approved Humira®. PK is the abbreviation of Pharmacokinetic(s).
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Population: The PK analysis set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 695501 | AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira® | 2630 µg*h/mL | Geometric Coefficient of Variation 52.6 |
| US-licensed Humira® | AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira® | 2470 µg*h/mL | Geometric Coefficient of Variation 51.3 |
| EU-approved Humira® | AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira® | 2640 µg*h/mL | Geometric Coefficient of Variation 38.5 |
90% CI: [98.54, 119.9]
90% CI: [92.51, 111.05]
90% CI: [86.01, 102.82]
Secondary
Number (Proportion) of Subjects With Drug Related Adverse Events
All events with an onset after the first administration of the trial medication up to a period of 70 days after the last administration of the trial medication (i.e., end of the REP) was assigned to the treatment phase for evaluation and was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication. All safety data were displayed and analyzed using descriptive statistical methods. No formal inferential analyses were planned for safety comparisons. Tabulations of frequencies and proportions, as appropriate were used for the evaluation of categorical (qualitative) data, and tabulations of descriptive statistics were used to analyze continuous (quantitative) data.
Time frame: Day 1 through Day 71
Population: The safety analysis set consisted of all subjects who received the single dose of trial medication (BI 695501, US-licensed Humira® or EU-approved Humira®).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BI 695501 | Number (Proportion) of Subjects With Drug Related Adverse Events | 21 participants |
| US-licensed Humira® | Number (Proportion) of Subjects With Drug Related Adverse Events | 29 participants |
| EU-approved Humira® | Number (Proportion) of Subjects With Drug Related Adverse Events | 28 participants |