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This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 695501 | Experimental | Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501 |
|
| adalimumab - US | Active Comparator | Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab |
|
| adalimumab - EU | Active Comparator | Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Drug | 40mg adalimumab single s.c. injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
| Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
| Maximum Measured Concentration of the BI 695501 in Plasma (Cmax) | Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal Half- Life of the BI 695501 in Plasma (t1/2) | Terminal half- life of the BI 695501 in plasma (t1/2). | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
| Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1297.1.002 Boehringer Ingelheim Investigational Site | Auckland | New Zealand | ||||
| 1297.1.001 Boehringer Ingelheim Investigational Site |
Subjects were screened for eligibility to participate in the trial. They attended a specialist sites which ensured strict implementation of inclusion/exclusion criteria and they were not to be entered in trial if any one of the specific entry criteria was violated. They were free to withdraw their consent at any time without penalty or prejudice.
This was phase I, open-label, randomised, parallel-arm, single-dose, active -comparator study with healthy subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 695501 | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501 |
| FG001 | Humira®US | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US |
| FG002 | Humira®EU | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): This set included all entered subjects who were treated with study medication and were documented to have received one dose of study drug. The TS contained all 193 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 695501 | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501 |
| BG001 | Humira®US | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated Set |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micro-gram*hour/milliliter (μg*h/mL) | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
|
From the first dose of study drug until end of the study, up to 79 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 695501 | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| BI695501 |
| Drug |
BI 695501 single s.c injection |
|
| adalimumab | Drug | 40mg adalimumab single s.c. injection |
|
Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F). |
| 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
| Christchurch |
| New Zealand |
| Lost to Follow-up |
|
| BG002 | Humira®EU | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Treated Set | Count of Participants | Participants |
|
| Race (NIH/OMB) | Ethnicity was not captured in this trial | Treated Set | Count of Participants | Participants |
|
Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) BI 695501
| OG001 | Humira®US | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US |
| OG002 | Humira®EU | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU |
|
|
|
| Primary | Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micro-gram*hour/milliliter (μg*h/mL) | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
|
|
|
|
| Primary | Maximum Measured Concentration of the BI 695501 in Plasma (Cmax) | Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic. | Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micro-gram/milliliter (μg/mL) | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
|
|
|
|
| Secondary | Terminal Half- Life of the BI 695501 in Plasma (t1/2) | Terminal half- life of the BI 695501 in plasma (t1/2). | Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
|
|
|
| Secondary | Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F) | Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F). | Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliter per minute (mL/min) | 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 35 |
| 67 |
| EG001 | Humira®US | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®US | 0 | 62 | 0 | 62 | 29 | 62 |
| EG002 | Humira®EU | Subject received one subcutaneous injection via prefilled syringe containing 40 milligram (mg) /0.8 milliliter (mL) Humira®EU | 0 | 64 | 0 | 64 | 33 | 64 |
| Rhinitis | Infections and infestations | 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 15.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | 15.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect. | ANOVA | 0.6547 | Geometric mean ratio (%) | 128.88 | Standard Error of the Mean | 1.080 | 2-Sided | 90 | 113.492 | 146.365 | Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error. | Equivalence | p-value for ratio outside interval 80% to 125% |
| ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect. | ANOVA | 0.1572 | Geometric mean ratio (%) | 86.24 | Standard Error of the Mean | 1.077 | 2-Sided | 90 | 76.238 | 97.564 | Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error. | Equivalence | p-value for ratio outside interval 80% to 125% |
| ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect. | ANOVA | 0.1700 | Geometric mean ratio (%) | 117.53 | Standard Error of the Mean | 1.066 | 2-Sided | 90 | 105.638 | 130.757 | Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error. | Equivalence | p-value for ratio outside interval 80% to 125% |
| ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect. | ANOVA | 0.0016 | Geometric mean ratio (%) | 96.53 | Standard Error of the Mean | 1.064 | 2-Sided | 90 | 87.064 | 107.017 | Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error. | Equivalence | p-value for ratio outside interval 80% to 125% |