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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Eptinezumab Yeast Cell Line; Drug: Eptinezumab Mammalian Cell Line

Study type: Interventional

Funder types: Industry

Identifiers

NCT05074459

19889A

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Eptinezumab Mammalian Cell Line

Experimental group

Description:

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

Treatment:

Drug: Eptinezumab Mammalian Cell Line

Eptinezumab Yeast Cell Line

Active Comparator group

Description:

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

Treatment:

Drug: Eptinezumab Yeast Cell Line