At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 78 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.
Single-blind, Partially Randomised, Placebo-controlled Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous Doses of BI 655130 in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 655130 (spesolimab) and Placebo for Healthy. Completed, enrolled 78 participants across 1 site.
Detailed Summary
The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2015
Primary CompletionMay 2016
TodayJul 2026
First PostedAug 17, 2015
Enrollment StartSep 14, 2015
Primary CompletionMay 27, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.9 years ago
Interventions
BI 655130 (spesolimab)drug
Placebodrug