At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 245 enrolled
Drug / intervention
Ixekizumabdrug
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.
Bioequivalence of an Alternate Ixekizumab Formulation Compared to the Commercial Formulation in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Ixekizumab for Healthy. Completed, enrolled 245 participants across 4 sites.
Detailed Summary
The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Information about any side effects that may occur will also be collected. The study will last up to about four months for each participant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartFeb 2020
First PostedFeb 2020
Primary CompletionFeb 2021
TodayJul 2026
First PostedFeb 6, 2020
Enrollment StartFeb 5, 2020
Primary CompletionFeb 19, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.4 years ago
Interventions
Ixekizumabdrug
Administered SC.