HealthyPhase 1NCT06520514
A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
A Phase 1 study testing Spesolimab in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.
Trial summary
The main objectives of this trial is to investigate the safety and tolerability of a single dose of spesolimab administered in 2 different ways in healthy subjects. 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?
- Spesolimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Aug 2024to 4 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Age of 18 to 50 years (inclusive).
- Body mass index (BMI) of 18.5 to 30.0 kg/m^2 (inclusive).
- Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Women of childbearing potential (WOCBP) must meet any of the following criteria for a highly effective contraception starting from at least 30 days before the administration of trial medication until 16 weeks after the injection/infusion of trial medication:
- Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal),
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- Use of progestogen-only hormonal contraception that inhibits ovulation (oral, injectable or implantable),
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS),
- Bilateral tubal occlusion/ ligation,
- A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm in ejaculate) and provided that partner is the sole sexual partner of the woman of childbearing potential trial participant,
- Complete abstinence (refraining from heterosexual intercourse) is considered a highly effective method of contraception only if it is in line with the preferred and usual lifestyle of the trial participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to trial investigational medicinal product, and withdrawal (coitus interruptus) are not acceptable.
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- Any evidence of a concomitant disease assessed 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.
- Participants with relevant chronic infections as determined by the investigator, including active or latent tuberculosis, Human Immunodeficiency Virus (HIV) or viral hepatitis. The corresponding laboratory tests will be performed during screening. In case of a positive hepatitis C antibody test, a positive reflex testing for Hepatitis C RNA (Ribonucleic Acid) PCR (polymerase chain reaction) is considered positive. For hepatitis B, exclusion criterion is met with either a positive Hepatitis B surface antigen or a positive Hepatitis B virus (HBV) DNA (Deoxyribonucleic Acid) PCR (HBV DNA PCR is done in case of positive Hepatitis core antibody and negative Hepatitis B surface antigen.).
- Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Relative Bioavailability of a Single Dose of Spesolimab Via Two Subcutaneous Modes of Delivery in Healthy Subjects (Mono-centric, Randomised, Parallel Group Design)
The main objectives of this trial is to investigate the safety and tolerability of a single dose of spesolimab administered in 2 different ways in healthy subjects.
- Conditions
- Healthy
- Being tested
- Spesolimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpesolimabDrug
Also called BI 655130
Spesolimab
| Study group | Role | What they receive |
|---|---|---|
| Reference group | Active comparator | Reference treatment using the standard administration mode Receives: Drug: Spesolimab |
| Test 1 group | Experimental | Treatment 1 using the test administration mode Receives: Drug: Spesolimab |
| Test 2 group | Experimental | Treatment 2 using the test administration mode Receives: Drug: Spesolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any treatment-emergent adverse event
Measured: Up to day 120
Secondary outcomes (3)
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: Up to day 120
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to day 120
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start7 Aug 2024
- Primary completion15 Jan 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520514
- Sponsor's protocol ID
- 1368-0151
- Other IDs
- 2023-510448-20-00, U1111-1301-8808, 2023
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Relative Bioavailability of a Single Dose of Spesolimab Via Two Subcutaneous Modes of Delivery in Healthy Subjects (Mono-centric, Randomised, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT06520514
- Acronym / sponsor ID
- 1368-0151
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this trial is to investigate the safety and tolerability of a single dose of spesolimab administered in 2 different ways in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference group | Active comparator | Drug: SpesolimabReference treatment using the standard administration mode |
| Test 1 group | Experimental | Drug: SpesolimabTreatment 1 using the test administration mode |
| Test 2 group | Experimental | Drug: SpesolimabTreatment 2 using the test administration mode |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Age of 18 to 50 years (inclusive).
- Body mass index (BMI) of 18.5 to 30.0 kg/m^2 (inclusive).
- Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Women of childbearing potential (WOCBP) must meet any of the following criteria for a highly effective contraception starting from at least 30 days before the administration of trial medication until 16 weeks after the injection/infusion of trial medication:
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- Any evidence of a concomitant disease assessed 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.
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 |
|---|---|---|
| SpesolimabAlso: BI 655130Spesolimab | Drug | Reference group, Test 1 group, Test 2 group |
Primary outcome
Occurrence of any treatment-emergent adverse event
Time frame: Up to day 120
3 secondary outcomes
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: Up to day 120
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to day 120
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- 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 Spesolimab 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 11 inclusion and 8 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 29 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of any treatment-emergent adverse event (time frame: Up to day 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.