HealthyPhase 1NCT03617835

A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body

A Phase 1 study testing R - Low dose of BI 655130, T1 - Low dose of BI 655130 and T2 - Low dose of BI 655130 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this trial is to investigate the relative bioavailability of BI 655130 administered as two subcutaneous injections in the left and right periumbilical region compared to a single subcutaneous periumbilical injection of BI 655130. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: R - Low dose of BI 655130, T1 - Low dose of BI 655130 and T2 - Low dose of BI 655130
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteBelgium
Study dates: 16 Aug 2018to 3 Jun 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Show all 26Show fewer

History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication up to 4 weeks after administration
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Female subjects will not be allowed to participate if any of the following applies:
Positive pregnancy test, pregnancy or plans to become pregnant up to study completion
Lactation
In addition, the following trial-specific exclusion criterion applies:
Previous use of the trial medication

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS Life Science Services - Clinical Research
Edegem, 2650

Other trials in Belgium

About this study

Official title: Relative Bioavailability, Safety, and Tolerability Following Subcutaneous Injection of Different Doses of BI 655130 and Different Injection Sites in Healthy Male and Female Subjects (a Single Dose, Mono-centric, Open-label Study in Matched-group Design).

The secondary objective is to investigate the relative bioavailability of a single subcutaneous injection of BI 655130 into the thigh compared to a single subcutaneous periumbilical injection of BI 655130.

Conditions: Healthy
Being tested: R - Low dose of BI 655130, T1 - Low dose of BI 655130, T2 - Low dose of BI 655130, T3 - High dose of BI 655130

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

R - Low dose of BI 655130Drug
Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.
T1 - Low dose of BI 655130Drug
Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
T2 - Low dose of BI 655130Drug
Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
T3 - High dose of BI 655130Drug
Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.

Study groups in NCT03617835
Study group	Role	What they receive
R - Low dose of BI 655130 Periumbilical	Experimental	Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours. Receives: Drug: R - Low dose of BI 655130
T1 - Low dose of BI 655130 Periumbilical (left and right)	Experimental	Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours. Receives: Drug: T1 - Low dose of BI 655130
T2 - Low dose of BI 655130 Thigh	Experimental	Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours. Receives: Drug: T2 - Low dose of BI 655130
T3 - High dose of BI 655130 Periumbilical (left and right)	Experimental	Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours. Receives: Drug: T3 - High dose of BI 655130

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Measured: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
mL = milliliter, mg = milligram.
Measured: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)
Maximum measured concentration of BI 655130 in plasma (Cmax). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Measured: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized
Maximum measured concentration of BI 655130 in plasma (Cmax), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Measured: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.

Secondary outcomes (2)

Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Measured: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
mL = milliliter, mg = milligram.
Measured: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 20183 Jun 2019

First posted6 Aug 2018
Study start16 Aug 2018
Primary completion3 Jun 2019
Study completion3 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03617835
Sponsor's protocol ID: 1368-0029
Other IDs: 2018-001074-18, 2018
Status last verified: Oct 2025
First submitted: 1 Aug 2018
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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: https://www.mystudywindow.com/msw/datatransparency

Publications

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.
PubMed 36451029

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability, Safety, and Tolerability Following Subcutaneous Injection of Different Doses of BI 655130 and Different Injection Sites in Healthy Male and Female Subjects (a Single Dose, Mono-centric, Open-label Study in Matched-group Design).
ClinicalTrials.gov ID: NCT03617835
Acronym / sponsor ID: 1368-0029
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 16 Aug 2018 (actual)
Primary completion: 3 Jun 2019 (actual)
Study completion: 3 Jun 2019 (actual)
First posted: 6 Aug 2018 (actual)
Results: Posted 15 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
R - Low dose of BI 655130 Periumbilical	Experimental	Drug: R - Low dose of BI 655130Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.
T1 - Low dose of BI 655130 Periumbilical (left and right)	Experimental	Drug: T1 - Low dose of BI 655130Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
T2 - Low dose of BI 655130 Thigh	Experimental	Drug: T2 - Low dose of BI 655130Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
T3 - High dose of BI 655130 Periumbilical (left and right)	Experimental	Drug: T3 - High dose of BI 655130Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (26 listed)

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
R - Low dose of BI 655130Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	Drug	R - Low dose of BI 655130 Periumbilical
T1 - Low dose of BI 655130Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	Drug	T1 - Low dose of BI 655130 Periumbilical (left and right)
T2 - Low dose of BI 655130Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.	Drug	T2 - Low dose of BI 655130 Thigh
T3 - High dose of BI 655130Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	Drug	T3 - High dose of BI 655130 Periumbilical (left and right)

Primary outcome

Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Maximum measured concentration of BI 655130 in plasma (Cmax). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Maximum measured concentration of BI 655130 in plasma (Cmax), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.

2 secondary outcomes

Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.

Results and safety

Results posted to the registry on 15 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R - Low Dose of BI 655130 Periumbilical	12	12
T1 - Low Dose of BI 655130 Periumbilical (Left and Right)	12	12
T2 - Low Dose of BI 655130 Thigh	12	12
T3 - High Dose of BI 655130 Periumbilical (Left and Right)	12	12

Primary outcome: Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.. Geometric least squares mean (Standard Error). Unit: day * microgram / milliliter

Measure	R - Low Dose of BI 655130 Periumbilical n = 12	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n = 12	T2 - Low Dose of BI 655130 Thigh n = 12
Value	1227.91 (NA)	1150.18 (NA)	1718.47 (NA)

R - Low Dose of BI 655130 Periumbilical vs T1 - Low Dose of BI 655130 Periumbilical (Left and Right): Ratio of the geometric means (T1/R) [%]: 93.67 (90% CI 78.48 to 111.80)
R - Low Dose of BI 655130 Periumbilical vs T2 - Low Dose of BI 655130 Thigh: Ratio of the geometric means (T2/R) [%]: 139.95 (90% CI 117.26 to 167.03)

Population analysed: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.

Primary outcome: Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized

Measure	R - Low Dose of BI 655130 Periumbilical n = 12	T3 - High Dose of BI 655130 Periumbilical (Left and Right) n = 12
Value	4.09 (NA)	4.99 (NA)

R - Low Dose of BI 655130 Periumbilical vs T3 - High Dose of BI 655130 Periumbilical (Left and Right): Ratio of the geometric means (T3/R) [%]: 121.84 (90% CI 102.08 to 145.41)

Primary outcome: Maximum Measured Concentration of BI 655130 in Plasma (Cmax)

Measure	R - Low Dose of BI 655130 Periumbilical n = 12	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n = 12	T2 - Low Dose of BI 655130 Thigh n = 12
Value	24.56 (NA)	24.35 (NA)	38.36 (NA)

R - Low Dose of BI 655130 Periumbilical vs T1 - Low Dose of BI 655130 Periumbilical (Left and Right): Ratio of the geometric means (T1/R) [%]: 99.17 (90% CI 83.77 to 117.39)
R - Low Dose of BI 655130 Periumbilical vs T2 - Low Dose of BI 655130 Thigh: Ratio of the geometric means (T2/R) [%]: 156.20 (90% CI 131.95 to 184.90)

Primary outcome: Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized

Measure	R - Low Dose of BI 655130 Periumbilical n = 12	T3 - High Dose of BI 655130 Periumbilical (Left and Right) n = 12
Value	0.08 (NA)	0.11 (NA)

R - Low Dose of BI 655130 Periumbilical vs T3 - High Dose of BI 655130 Periumbilical (Left and Right): Ratio of the geometric means (T3/R) [%]: 138.34 (90% CI 116.87 to 163.77)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R - Low Dose of BI 655130 Periumbilical	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
T1 - Low Dose of BI 655130 Periumbilical (Left and Right)	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
T3 - High Dose of BI 655130 Periumbilical (Left and Right)	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
T2 - Low Dose of BI 655130 Thigh	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12

Limitations and caveats (from the sponsor): 07 Jan 2019: Amendment 2 was implemented after Independent Ethics Committee/Competent (Regulatory) authority approval. The residual effect period was changed from 176±3 days to 16 weeks for consistency across all clinical studies with BI 655130.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36451029Joseph 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing R - Low dose of BI 655130, T1 - Low dose of BI 655130 and T2 - Low dose of BI 655130 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03617835, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.