At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
Placebo +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 Single Rising Doses of BI 655064 (Buffer Solution for Injection) in Healthy Chinese and Japanese Male Volunteers (Randomised, Double-blind, Placebocontrolled Within Dose Groups, Clinical Phase I Study)
In Brief
A Phase 1 clinical trial evaluating Placebo and BI 655064 for Healthy. Completed, enrolled 64 participants across 2 sites in 2 countries.
Detailed Summary
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan, South Korea
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedAug 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedAug 7, 2013
Enrollment StartAug 5, 2013
Primary CompletionMay 14, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.9 years ago
Interventions
Placebodrug
Solution for subcutaneous (s.c.) injection.
BI 655064drug
Solution for subcutaneous (s.c.) injection.