drugset / Trial / NCT05074459

A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines

NCT05074459

Phase 1 Completed 84 enrolled H. Lundbeck A/S
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-09-27
Primary completion
2022-07-18
Completion
2022-07-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Eptinezumab Monoclonal antibody Intravenous

Indications

No indication recorded.