At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
BI 655130drug
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 Two Dose Strengths of a Single Subcutaneous Dose of BI 655130 and One Single Intravenous Dose of BI 655130 in Healthy Male and Female Subjects (Open-label, Parallel Group Design)
In Brief
A Phase 1 clinical trial evaluating BI 655130 for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The primary objective of this trial is to investigate the relative bioavailability of BI 655130 following subcutaneous administration (Test, T) compared to BI 655130 following intravenous infusion (Reference, R). The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between all tested treatments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartApr 2017
Primary CompletionJan 2018
TodayJul 2026
First PostedApr 4, 2017
Enrollment StartApr 24, 2017
Primary CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.2 years ago
Interventions
BI 655130drug
single dose