CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 240 enrolled
Drug / intervention
Mirikizumab Prefilled Syringe +1 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/NCT04607733
NCT04607733Phase 1Completed
CompareCT.gov

A Bioequivalence Study of Injections of Mirikizumab Solution Using an Investigational 1-mL Pre-Filled Syringe and an Investigational 1-mL Autoinjector in Healthy Participants

Eli Lilly and Company·interventional·Posted Oct 29, 2020·Updated Feb 20, 2024

In Brief

A Phase 1 clinical trial evaluating Mirikizumab Prefilled Syringe and Mirikizumab Autoinjector for Healthy. Completed, enrolled 240 participants across 4 sites.

Detailed Summary

The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 28 days prior to the start of the study. 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
202120222023202420252026
First PostedOct 29, 2020
Enrollment StartNov 2, 2020
Primary CompletionMay 17, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.7 years ago

Interventions

Mirikizumab Prefilled Syringedrug

Administered SC by prefilled syringe

Mirikizumab Autoinjectordrug

Administered SC by autoinjector