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Monoclonal Antibodies

Eptinezumab Mammalian Cell Line for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose up to 12 hours after the end of the infusion) up to day 112 (after the end of the infusion), and at the follow-up visit day 140
Awards & highlights

Study Summary

This study is evaluating whether a new cell line for making eptinezumab will affect how the drug behaves in the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose up to 12 hours after the end of the infusion) up to day 112 (after the end of the infusion), and at the follow-up visit day 140
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose up to 12 hours after the end of the infusion) up to day 112 (after the end of the infusion), and at the follow-up visit day 140 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)
Secondary outcome measures
Apparent Terminal Elimination Half-Life (t½)
Apparent Volume of Distribution (Vz)
Area Under the Plasma Concentration-Time Curve From Zero to Time t (AUC0-t)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Eptinezumab Mammalian Cell LineExperimental Treatment1 Intervention
Participants will receive a single intravenous (IV) infusion of eptinezumab mammalian cell line on Day 1.
Group II: Eptinezumab Yeast Cell LineActive Control1 Intervention
Participants will receive a single IV infusion of eptinezumab yeast cell line on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab Mammalian Cell Line
2021
Completed Phase 1
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,499 Total Patients Enrolled
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,256 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines
2021. "A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05074459.
~24 spots leftby Apr 2025
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