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NCT05644353 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 450
- Enrollment target
NCT05644353: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT05644353 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 450 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (650% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05644353, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 450 participants
- Enrollment target
Study 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 pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. 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.
Primary Outcome
PK: Cmax of Mirikizumab
Interventions
- DRUG Mirikizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2023-05-25 |
| Phase | Phase 1 |
What the finished NCT05644353 record still lists
NCT05644353 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (650% higher).
The record links to 0 conditions, and to 1 intervention - of which Mirikizumab is the first listed.
NCT05644353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05644353 about?
NCT05644353 is a clinical study titled "A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants". 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 pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse e...
What is the current status of trial NCT05644353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 450 participants. The study started on 2022-12-05. Estimated completion is 2023-05-25.
What interventions are being tested in trial NCT05644353?
The interventions under investigation include: Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT05644353?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05644353's enrollment target sits among peer trials
450 54th of 2000 higher than 1,944 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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