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

NCT05074459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-08-29

No results posted yet for this 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.

Conditions

  • Healthy Participants

Interventions

DRUG

Eptinezumab Mammalian Cell Line

Concentrate for solution for IV infusion

DRUG

Eptinezumab Yeast Cell Line

Concentrate for solution for IV infusion

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

  • Email contact via H. Lundbeck A/S · H. Lundbeck A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2022-07-18
Completion
2022-07-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074459 on ClinicalTrials.gov