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

NCT05074459 | Completed Phase 1 FDA Drug

• 1 other identifier: 19889A
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Eptinezumab Mammalian Cell Line

EXPERIMENTAL

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

Drug: Eptinezumab Mammalian Cell Line

Eptinezumab Yeast Cell Line

ACTIVE COMPARATOR

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

Drug: Eptinezumab Yeast Cell Line

Interventions

Eptinezumab Mammalian Cell Line DRUG

Concentrate for solution for IV infusion

Eptinezumab Mammalian Cell Line

Eptinezumab Yeast Cell Line DRUG

Concentrate for solution for IV infusion

Eptinezumab Yeast Cell Line

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (2)

Labcorp Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

Location

Labcorp Clinical Research Unit, Inc.

Madison, Wisconsin, 53715, United States

Location

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: September 27, 2021
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (2)