HealthyPhase 1NCT02852824
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers
A Phase 1 study testing BI 655130 (spesolimab) in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 655130 (spesolimab)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Aug 2016to 1 Aug 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male 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 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 and local legislation
Who cannot join
- 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 45 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
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects
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.
- Conditions
- Healthy
- Being tested
- BI 655130 (spesolimab), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 655130 (spesolimab)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 655130 (spesolimab) | Experimental | Not described Receives: Drug: BI 655130 (spesolimab) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Drug-related Adverse Events (AEs).
Percentage of subjects with investigator defined drug-related adverse events (AEs).
Measured: From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part)
Secondary outcomes (5)
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).
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 4200 hours. Individual time points are provided in detail in description.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start10 Aug 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852824
- Sponsor's protocol ID
- 1368.2
- Other IDs
- 2016-001235-12, 2016
- Status last verified
- Sep 2023
- First submitted
- 29 Jul 2016
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02852824
- Acronym / sponsor ID
- 1368.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 655130 (spesolimab) | Experimental | Drug: BI 655130 (spesolimab) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male 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 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 and local legislation
Key exclusion criteria (8 listed)
- 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 45 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
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 |
|---|---|---|
| BI 655130 (spesolimab) | Drug | BI 655130 (spesolimab) |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of Subjects With Drug-related Adverse Events (AEs).
Time frame: From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part)
Percentage of subjects with investigator defined drug-related adverse events (AEs).
5 secondary outcomes
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 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.
Maximum Measured Concentration of the BI 655130 in Plasma (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 4200 hours. Individual time points are provided in detail in description.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 BI 655130 (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 4 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 18 Mar 2024. 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. Some participants in this study may receive a placebo. 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 18 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?
Percentage of Subjects With Drug-related Adverse Events (AEs). (time frame: From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part)). 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 NCT02852824, 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 18 Mar 2024.