At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
BI 655130 (spesolimab) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating BI 655130 (spesolimab) and Placebo for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartAug 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedAug 2, 2016
Enrollment StartAug 10, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.9 years ago
Interventions
BI 655130 (spesolimab)drug
Placebodrug