A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Spesolimab

• Registration Number: NCT06520514
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-08-07
• Primary Completion: 2025-01-15
• Study Completion: 2025-02-04
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference group	Spesolimab	Reference treatment using the standard administration mode
Test 2 group	Spesolimab	Treatment 2 using the test administration mode
Test 1 group	Spesolimab	Treatment 1 using the test administration mode

Primary Outcome Measures

Name	Time	Method
Occurrence of any treatment-emergent adverse event	Up to day 120

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	Up to day 120
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)	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)	Up to day 120

Trial Locations

Locations (1)

SGS Life Science Services - Clinical Research; 🇧🇪 Edegem, Belgium