CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 396 enrolled
Drug / intervention
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.

Search/NCT05515601
NCT05515601Phase 1Completed

A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using an Investigational 1-mL Autoinjector and Mirikizumab Test Solution Formulation Using an Investigational 1-mL Autoinjector in Healthy Participants

Eli Lilly and Company·interventional·Posted Aug 25, 2022·Updated Jul 5, 2024

In Brief

A Phase 1 clinical trial evaluating Mirikizumab for Healthy. Completed, enrolled 396 participants across 6 sites.

Detailed Summary

The main purpose of this study is to evaluate 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 compared to mirikizumab (reference) solution given via autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedAug 25, 2022
Enrollment StartAug 31, 2022
Primary CompletionFeb 20, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.9 years ago

Interventions

Mirikizumabdrug

Administered SC.