At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
BI 655064 +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 Subcutaneous Doses of BI 655064 in Healthy Chinese Male Volunteers (Randomised, Double-blind, Placebo-controlled, Clinical Phase I Study)
In Brief
A Phase 1 clinical trial evaluating BI 655064 and Placebo for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers. The secondary objective is the exploratory evaluation of the pharmacokinetics and pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartSep 2015
Primary CompletionMay 2016
TodayJul 2026
First PostedJan 6, 2015
Enrollment StartSep 1, 2015
Primary CompletionMay 25, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.5 years ago
Interventions
BI 655064drug
subcutaneous injection
Placebodrug
Placebo