CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 327 enrolled
Drug / intervention
BI 695501 +2 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.

Search/NCT02045979
NCT02045979Phase 1Completed
CompareCT.gov

Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Double-blind, Single Dose, Parallel-arm, Active Comparator Clinical Phase I Study

Boehringer Ingelheim·interventional·Posted Jan 27, 2014·Updated Jun 20, 2018

In Brief

A Phase 1 clinical trial evaluating BI 695501, adalimumab-EU source, and 1 other intervention for Healthy. Completed, enrolled 327 participants across 3 sites in 2 countries.

Detailed Summary

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium, New Zealand
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 27, 2014
Enrollment StartJan 31, 2014
Primary CompletionJun 20, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.4 years ago

Interventions

BI 695501drug

BI 695501 single s.c. injection

adalimumab-EU sourcedrug

adalimumab-EU source single s.c. injection

adalimumab-US sourcedrug

adalimumab-US source single s.c. injection.