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NCT05074459 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines
A Phase 1 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT05074459 is a Phase 1 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 84 participants.
The verdict
NCT05074459, a Phase 1 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
Eptinezumab is a preventive treatment for migraine. The drug is made from a process that currently uses yeast cells for production of the drug. The trial researchers want to test whether using a new production cell line to make eptinezumab will affect the way the drug behaves in the body. To do this, the researchers will give a single dose of eptinezumab to healthy participants. Some of the participants will get eptinezumab that has been made from yeast cells. Others will get eptinezumab made with the new cell line.
Interventions
- DRUG Eptinezumab Mammalian Cell Line
- DRUG Eptinezumab Yeast Cell Line
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2022-07-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05074459
The ClinicalTrials.gov registry entry for NCT05074459 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lundbeck A/S, which has 72 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Eptinezumab Mammalian Cell Line is the first listed.
NCT05074459 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05074459 about?
NCT05074459 is a clinical study titled "A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines". Eptinezumab is a preventive treatment for migraine. The drug is made from a process that currently uses yeast cells for production of the drug. The trial researchers want to test whether using a new production cell line to make eptinezumab will affect the way the drug behaves in the body. To do this...
What is the current status of trial NCT05074459?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-09-27. Estimated completion is 2022-07-18.
What interventions are being tested in trial NCT05074459?
The interventions under investigation include: Eptinezumab Mammalian Cell Line (DRUG), Eptinezumab Yeast Cell Line (DRUG).
Who is sponsoring clinical trial NCT05074459?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
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