Adults 20 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With Drug-related Adverse Events (AEs)Primary· From first drug administration until the end of trial examination, up to 151 days.
The primary endpoint is to assess safety and tolerability of spesolimab as the number \[N\] of subjects with drug-related AEs.
Group
Value
95% CI
Spesolimab Low Dose Group (Intravenous)
0
Spesolimab Medium Dose Group (Intravenous)
0
Spesolimab High Dose Group (Intravenous)
0
Spesolimab Low Dose Group (Subcutaneous)
0
Placebo Matching to Spesolimab
0
Area Under the Concentration-time Curve of Spesolimab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)Secondary· Up to 3528 hours after administration of spesolimab.
AUC0-∞, Area under the concentration-time curve of spesolimab in plasma over the time interval from 0 extrapolated to infinity is presented.
Pharmacokinetic samples were collected within 2 hours pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with intravenous administration of spesolimab.
Pharmacokinetic samples were collected within 2 hours pre-dose and at 0.5, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose grou
Group
Value
95% CI
Spesolimab Low Dose Group (Intravenous)
1890
± 19.9
Spesolimab Medium Dose Group (Intravenous)
3930
± 18.4
Spesolimab High Dose Group (Intravenous)
7060
± 18.0
Spesolimab Low Dose Group (Subcutaneous)
1390
± 24.8
Maximum Measured Concentration of Spesolimab in Plasma (Cmax)Secondary· Up to 3528 hours after administration of spesolimab.
Cmax, maximum measured concentration of spesolimab in plasma is presented. Pharmacokinetic samples were collected within 2 hours pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with intravenous administration of Up to 3528 hours after administration of spesolimab.
Pharmacokinetic samples were collected within 2 hours pre-dose and at 0.5, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 hours after dosing of dose groups with subcutaneous admin
Group
Value
95% CI
Spesolimab Low Dose Group (Intravenous)
99.7
± 10.4
Spesolimab Medium Dose Group (Intravenous)
193.0
± 17.9
Spesolimab High Dose Group (Intravenous)
400.0
± 12.9
Spesolimab Low Dose Group (Subcutaneous)
32.2
± 21.8
Total Clearance of Spesolimab in Plasma After Intravenous Administration (CL)Secondary· Pharmacokinetic samples were collected within 2 hours (h) pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 h after dosing of dose groups with intravenous administration of spesolimab.
CL, total clearance of spesolimab in plasma after intravenous administration is presented for intravenous dose groups.
Group
Value
95% CI
Spesolimab Low Dose Group (Intravenous)
0.159
± 19.9
Spesolimab Medium Dose Group (Intravenous)
0.153
± 18.4
Spesolimab High Dose Group (Intravenous)
0.170
± 18.0
Volume of Distribution at Steady State After Intravenous Administration of Spesolimab (Vss)Secondary· Pharmacokinetic samples were collected within 2 hours (h) pre-dose and at 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856 and 3528 h after dosing of dose groups with intravenous administration of spesolimab.
Vss, volume of distribution at steady state after intravenous administration of spesolimab is presented for intravenous dose groups.
Group
Value
95% CI
Spesolimab Low Dose Group (Intravenous)
6.19
± 18.1
Spesolimab Medium Dose Group (Intravenous)
6.97
± 11.9
Spesolimab High Dose Group (Intravenous)
6.60
± 11.6
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration until the end of trial examination, up to 151 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this trial is to investigate the safety and tolerability of spesolimab following administration of single rising intravenous doses and single subcutaneous dose in healthy Japanese male volunteers.
Secondary objective is the exploration of the pharmacokinetics including dose proportionality of spesolimab in healthy Japanese male volunteers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06624670 — A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
· Phase 3
· recruiting
NCT06520514 — A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
· Phase 1
· completed
NCT06241573 — A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurat
· Phase 2, PHASE3
· terminated
NCT06013969 — A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeate
· Phase 4
· active not recruiting
NCT06707207 — Predicting Future Errors During Skill Performance
· recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
· Phase 1
· recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.
· NA
· recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects
· NA
· recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
· Phase 1, PHASE2
· recruiting
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· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 6 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03123094.