At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 498 enrolled
Drug / intervention
Citrate-Free Mirikizumabdrug
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.
A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating Citrate-Free Mirikizumab for Healthy. Completed, enrolled 498 participants across 6 sites.
Detailed Summary
The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector. Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
Enrollment StartJun 2024
First PostedJun 2024
Primary CompletionDec 2024
TodayJul 2026
First PostedJun 26, 2024
Enrollment StartJun 24, 2024
Primary CompletionDec 27, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.0 years ago
Interventions
Citrate-Free Mirikizumabdrug
Administered SC