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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05074459
• Other study ID #: 19889A
• Status: Completed
• Phase: Phase 1
• Start date: September 27, 2021
• Est. completion date: July 18, 2022

Study information

• Verified date: August 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Eptinezumab Mammalian Cell Line
Concentrate for solution for IV infusion
• Eptinezumab Yeast Cell Line
Concentrate for solution for IV infusion

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit, Inc.	Daytona Beach	Florida
United States	Labcorp Clinical Research Unit, Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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