Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects

Safety, Tolerability, and Pharmacokinetics of Two Dose Strengths of a Single Subcutaneous Dose of BI 655130 and One Single Intravenous Dose of BI 655130 in Healthy Male and Female Subjects (Open-label, Parallel Group Design)

The primary objective of this trial is to investigate the relative bioavailability of BI 655130 following subcutaneous administration (Test, T) compared to BI 655130 following intravenous infusion (Reference, R).

The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between all tested treatments.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 655130

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • SGS Life Science Services - Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP (Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
• Age of 18 to 50 years (incl.)
• BMI (Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and local legislation

• Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

  • Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
  • Sexually abstinent
  • A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
  • Surgically sterilised (including hysterectomy)
  • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

• Any finding in the medical examination (including BP (Blood Pressure), PR (Pulse Rate)), or ECG (Electrocardiogram),) 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 50 to 90 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
• 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 or during the trial
• 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 within 30 days after study completion
• Lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 655130 low dose SC; Subject received single low dose BI 655130 solution as subcutaneous (SC) injection on day 1.	Drug: BI 655130; single dose; Other Names: Spesolimab
Experimental: BI 655130 high dose SC; Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	Drug: BI 655130; single dose; Other Names: Spesolimab
Experimental: BI 655130 high dose IV; Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.	Drug: BI 655130; single dose; Other Names: Spesolimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 is presented. As defined in the statistical analysis plan, this outcome measure was analysed for comparison of subcutaneous (SC) versus intravenous (IV) administration of BI 655130 high dose as part of the primary analysis.	Pharmacokinetic samples were collected at pre-dose and at 0.5, 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 after drug administration.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)	Cmax, maximum measured concentration of BI 655130 in plasma is presented. As defined in the statistical analysis plan, this outcome measure was analysed for comparison of subcutaneous (SC) versus intravenous (IV) administration of BI 655130 high dose as part of the primary analysis.	Pharmacokinetic samples were collected at pre-dose and at 0.5, 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 after drug administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	AUC0-∞, area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 extrapolated to infinity is presented. As defined in the statistical analysis plan, this outcome measure was analysed for comparison of subcutaneous (SC) versus intravenous (IV) administration of BI 655130 high dose as part of the primary analysis.	Pharmacokinetic samples were collected at pre-dose and at 0.5, 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 after drug administration.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Investigators: Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: spesolimab
• Other Study ID Numbers: 1368.3; 2016-004557-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No