NCT05074459

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

Interventional, Randomized, Double-blind, Parallel-group, Healthy Subject, Single Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab Manufactured Using Two Different Cell Lines

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Eptinezumab Mammalian Cell Line	Concentrate for solution for IV infusion
DRUG	Eptinezumab Yeast Cell Line	Concentrate for solution for IV infusion

Timeline

• Start date: 2021-09-27
• Primary completion: 2022-07-18
• Completion: 2022-07-18
• First posted: 2021-10-12
• Last updated: 2022-08-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study