At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
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 and Pharmacokinetics of Single Rising Intravenous Dose and Single Subcutaneous Dose of BI 655130 in Healthy Japanese Male Volunteers (Double-blind, Randomised, Placebo-controlled Design).
In Brief
A Phase 1 clinical trial evaluating Spesolimab and Placebo for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionJan 2018
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartMay 16, 2017
Primary CompletionJan 4, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.2 years ago
Interventions
Spesolimabdrug
single dose
Placebodrug
single dose