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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Eptinezumab Mammalian Cell Line; Drug: Eptinezumab Yeast Cell Line

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Labcorp Clinical Research Unit, Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Labcorp Clinical Research Unit, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• The participant has a body weight ≥50 and ≤100 kilograms (kg).
• The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/meter (m^2) at the screening visit and at the baseline visit.
• The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the screening visit and at the baseline visit.
• The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the screening visit and at the baseline visit.
• The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Key Exclusion Criteria:

• The participant has taken disallowed medication <1 week prior to the dose of investigational medicinal product (IMP) or <5 half-lives prior to the screening visit for any medication taken.
• The participant has taken any IMP <3 months or <5 half-lives (whichever is longer) prior to the first dose of IMP.
• The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
• The participant has been dosed with a monoclonal antibody (mAb) ≤6 months prior to the screening visit.
• The participant is a smoker or uses other nicotine-containing products (for example, snuff, nicotine patches, nicotine chewing gum, mock cigarettes, inhalers). Ex-smokers must have ceased smoking >3 months prior to the screening visit.

Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eptinezumab Mammalian Cell Line; Participants will receive a single intravenous (IV) infusion of eptinezumab mammalian cell line on Day 1.	Drug: Eptinezumab Mammalian Cell Line; Concentrate for solution for IV infusion
Active Comparator: Eptinezumab Yeast Cell Line; Participants will receive a single IV infusion of eptinezumab yeast cell line on Day 1.	Drug: Eptinezumab Yeast Cell Line; Concentrate for solution for IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Extrapolated AUC of Total AUC0-inf (AUC%extr)	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
Maximal Observed Plasma Concentration (Cmax)	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
Area Under the Plasma Concentration-Time Curve From Zero to Time t (AUC0-t)	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
Apparent Terminal Elimination Half-Life (t½)	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
Systemic Clearance (CL), Defined as Dose/AUC0-inf	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
Apparent Volume of Distribution (Vz)	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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19889A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No