At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 193 enrolled
Drug / intervention
adalimumab +2 moredrug
Likely dose
adalimumab 40mgfrom 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.
Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Open-label, Single Dose, Parallel Arm, Active Comparator Clinical Phase I Study
In Brief
A Phase 1 clinical trial evaluating adalimumab and BI695501 for Healthy. Completed, enrolled 193 participants across 2 sites.
Detailed Summary
This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNew Zealand
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedJan 2012
Primary CompletionJul 2012
TodayJul 2026
First PostedJan 6, 2012
Enrollment StartDec 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.5 years ago
Interventions
adalimumabdrug
40mg adalimumab single s.c. injection
BI695501drug
BI 695501 single s.c injection
adalimumabdrug
40mg adalimumab single s.c. injection