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

NCT ID: NCT05074459

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2022-07-18

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Eptinezumab Mammalian Cell Line

Participants will receive a single intravenous (IV) infusion of eptinezumab mammalian cell line on Day 1.

Group Type: EXPERIMENTAL

Eptinezumab Mammalian Cell Line

Intervention Type: DRUG

Concentrate for solution for IV infusion

Eptinezumab Yeast Cell Line

Participants will receive a single IV infusion of eptinezumab yeast cell line on Day 1.

Group Type: ACTIVE_COMPARATOR

Eptinezumab Yeast Cell Line

Intervention Type: DRUG

Concentrate for solution for IV infusion

Interventions

Eptinezumab Mammalian Cell Line

Concentrate for solution for IV infusion

Intervention Type: DRUG

Eptinezumab Yeast Cell Line

Concentrate for solution for IV infusion

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

Labcorp Clinical Research Unit, Inc.

Daytona Beach, Florida, United States

Labcorp Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

19889A

Identifier Type: -

Identifier Source: org_study_id