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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001235-12 | EudraCT Number |
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The primary objective of this trial is to investigate the safety and tolerability of BI 655130 in healthy male subjects following IV administration of multiple rising doses. The study will also explore safety and tolerability following a single IV administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 655130 (spesolimab) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 655130 (spesolimab) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events (AEs). | Percentage of subjects with investigator defined drug-related adverse events (AEs). | From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞, Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity. This endpoint only applies to the single rising dose part (SD) (20 mg/kg BI 655130 single dose). | Pharmacokinetic samples were collected at 2 hours pre-dose and 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours after drug administration. |
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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 |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36451029 | Derived | Joseph D, Thoma C, Haeufel T, Li X. Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies. Clin Pharmacokinet. 2022 Dec;61(12):1771-1787. doi: 10.1007/s40262-022-01176-5. Epub 2022 Dec 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites to ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
The multiple rising dose (MRD) part of the trial was double-blind, randomised and placebo-controlled within parallel dose groups. The placebo-controlled single dose (SD) part was single-blind and partially randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching to BI 655130 Multiple Dose (MD) | Participants were administered multiple dose (4 single intravenous (IV) infusions 1 week apart) of 20 milligram per kilogram (mg/kg) solution for infusion of Placebo matching to BI 655130. |
| FG001 | 3 Milligram/Kilogram (mg/kg)] BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 3 mg/kg solution for infusion of BI 655130 |
| FG002 | 6 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 6 mg/kg solution for infusion of BI 655130. |
| FG003 | 10 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 10 mg/kg solution for infusion of BI 655130. |
| FG004 | 20 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 20 mg/kg solution for infusion of BI 655130. |
| FG005 | Placebo Matching to BI 655130 Single Dose (SD) | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of Placebo matching to BI 655130. |
| FG006 | 20 mg/kg BI 655130 Single Dose | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of BI 655130. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): This subject set included all subjects who received trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching to BI 655130 Multiple Dose (MD) | Participants were administered multiple dose (4 single intravenous (IV) infusions 1 week apart) of 20 milligram per kilogram (mg/kg) solution for infusion of Placebo matching to BI 655130. |
| BG001 | 3 Milligram/Kilogram (mg/kg)] BI 655130 MD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of signing informed consent form is presented. |
| 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 | Percentage of Subjects With Drug-related Adverse Events (AEs). | Percentage of subjects with investigator defined drug-related adverse events (AEs). | Treated set (TS): This subject set included all subjects who received trial drug. | Posted | Number | Percentage of participants | From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part) |
|
From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part)
The safety analysis was performed on the TS (The TS included all subjects who received trial drug.)
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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 | Placebo Matching to BI 655130 Multiple Dose (MD) | Participants were administered multiple dose (4 single intravenous (IV) infusions 1 week apart) of 20 milligram per kilogram (mg/kg) solution for infusion of Placebo matching to BI 655130. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2017 | Sep 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2017 | Sep 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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| Maximum Measured Concentration of the BI 655130 in Plasma (Cmax) | Cmax, maximum measured concentration of BI 655130 in plasma for single dose and multiple dose. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg SD: Samples were collected at 2 h pre-dose, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 h after dosing. | Up to 4200 hours. Individual time points are provided in detail in description. |
| Maximum Measured Concentration of BI 655130 in Plasma After the Fourth Dose (Cmax,4) | Cmax,4, maximum measured concentration of BI 655130 in plasma after the fourth dose. Steady state was not reached, therefore Cmax,ss is presented as Cmax,4. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. | Up to 4200 hours. Individual time points are provided in detail in description. |
| Area Under the Concentration-time Curve of the BI 655130 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1) | AUCτ,1, Area under the concentration-time curve of the BI 655130 in plasma over a uniform dosing interval τ after administration of the first dose. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. | Up to 4200 hours. Individual time points are provided in detail in description. |
| Area Under the Concentration Time Curve of BI 655130 in Plasma After the Fourth Dose (AUCτ,4) | AUCτ,4, area under the concentration time curve of BI 655130 in plasma after the fourth dose. Steady state was not reached, therefore AUCτ,ss is presented as AUCτ,4. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. | Up to 4200 hours. Individual time points are provided in detail in description. |
| Adverse Event |
|
Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 3 mg/kg solution for infusion of BI 655130 |
| BG002 | 6 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 6 mg/kg solution for infusion of BI 655130. |
| BG003 | 10 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 10 mg/kg solution for infusion of BI 655130. |
| BG004 | 20 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 20 mg/kg solution for infusion of BI 655130. |
| BG005 | Placebo Matching to BI 655130 Single Dose (SD) | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of Placebo matching to BI 655130. |
| BG006 | 20 mg/kg BI 655130 Single Dose | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of BI 655130. |
| BG007 | Total | Total of all reporting groups |
TS
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Number of subjects is categorized as Male or Female. | TS | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Number of subjects is categorized for ethnicity data. | TS | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number of subjects is categorized for race data. | TS | Count of Participants | Participants |
|
Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 3 mg/kg solution for infusion of BI 655130 |
| OG002 | 6 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 6 mg/kg solution for infusion of BI 655130. |
| OG003 | 10 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 10 mg/kg solution for infusion of BI 655130. |
| OG004 | 20 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 20 mg/kg solution for infusion of BI 655130. |
| OG005 | Placebo Matching to BI 655130 Single Dose (SD) | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of Placebo matching to BI 655130. |
| OG006 | 20 mg/kg BI 655130 Single Dose | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of BI 655130. |
|
|
| Secondary | Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞, Area under the concentration-time curve of the BI 655130 in plasma over the time interval from 0 extrapolated to infinity. This endpoint only applies to the single rising dose part (SD) (20 mg/kg BI 655130 single dose). | Pharmacokinetic parameter set (PKS):This subject set included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. Only subjects from SRD part were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day/milliliter [μg*day/mL] | Pharmacokinetic samples were collected at 2 hours pre-dose and 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours after drug administration. |
|
|
|
| Secondary | Maximum Measured Concentration of the BI 655130 in Plasma (Cmax) | Cmax, maximum measured concentration of BI 655130 in plasma for single dose and multiple dose. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg SD: Samples were collected at 2 h pre-dose, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 h after dosing. | Pharmacokinetic parameter set (PKS):This subject set included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. Subjects in SRD and MRD part were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter [μg/mL] | Up to 4200 hours. Individual time points are provided in detail in description. |
|
|
|
|
| Secondary | Maximum Measured Concentration of BI 655130 in Plasma After the Fourth Dose (Cmax,4) | Cmax,4, maximum measured concentration of BI 655130 in plasma after the fourth dose. Steady state was not reached, therefore Cmax,ss is presented as Cmax,4. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. | Pharmacokinetic parameter set (PKS):This subject set included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter [μg/mL] | Up to 4200 hours. Individual time points are provided in detail in description. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of the BI 655130 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1) | AUCτ,1, Area under the concentration-time curve of the BI 655130 in plasma over a uniform dosing interval τ after administration of the first dose. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. | Pharmacokinetic parameter set (PKS):This subject set included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day/milliliter [μg*day/mL] | Up to 4200 hours. Individual time points are provided in detail in description. |
|
|
|
|
| Secondary | Area Under the Concentration Time Curve of BI 655130 in Plasma After the Fourth Dose (AUCτ,4) | AUCτ,4, area under the concentration time curve of BI 655130 in plasma after the fourth dose. Steady state was not reached, therefore AUCτ,ss is presented as AUCτ,4. BI 655130: 3/6 mg/kg MD: Samples were collected at 2 hours(h) pre-dose, 0.5, 12, 24, 96, 166, 168.5, 180, 192, 264, 334, 336.5, 348, 360, 432, 502, 504.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 10 mg/kg MD: Samples were collected at 2 h pre-dose, 1, 12, 24, 96, 166, 169, 180, 192, 264, 334, 337, 348, 360, 432, 502, 505, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. 20 mg/kg MD: Samples were collected at 2 h pre-dose, 1.5, 12, 24, 96, 166, 169.5, 180, 192, 264, 334, 337.5, 348, 360, 432, 502, 505.5, 516, 528, 600, 672, 840, 1008, 1176, 1344, 1512, 1848, 2184, 2856, 3528 and 4200 h after dosing. | Pharmacokinetic parameter set (PKS):This subject set included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day/milliliter [μg*day/mL] | Up to 4200 hours. Individual time points are provided in detail in description. |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | 3 Milligram/Kilogram (mg/kg) BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 3 mg/kg solution for infusion of BI 655130 | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | 6 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 6 mg/kg solution for infusion of BI 655130. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | 10 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 10 mg/kg solution for infusion of BI 655130. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG004 | 20 mg/kg BI 655130 MD | Participants were administered multiple dose (4 single intravenous infusions 1 week apart) of 20 mg/kg solution for infusion of BI 655130. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Placebo Matching to BI 655130 Single Dose (SD) | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of Placebo matching to BI 655130. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG006 | 20 mg/kg BI 655130 Single Dose | Participants were administered single dose of 20 mg/kg solution for intravenous infusion of BI 655130. | 0 | 6 | 0 | 6 | 4 | 6 |
| Abdominal pain | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | 20.1 | Systematic Assessment |
|
| Feeling hot | General disorders | 20.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | 20.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | 20.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | 20.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | 20.1 | Systematic Assessment |
|
| Injection site pain | General disorders | 20.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | 20.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | 20.1 | Systematic Assessment |
|
| Malaise | General disorders | 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 20.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 20.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | 20.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment |
|
| Skin wound | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 20.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 20.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | 20.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
|
| Dandruff | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
|
| Dental care | Surgical and medical procedures | 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 20.1 | Systematic Assessment |
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