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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05074459
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Eptinezumab Mammalian Cell Line Drug: Eptinezumab Yeast Cell Line Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : June 27, 2022
Estimated Study Completion Date : June 27, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Area Under the Eptinezumab Plasma Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf) [ Time Frame: 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 :
  1. Percent Extrapolated AUC of Total AUC0-inf (AUC%extr) [ Time Frame: 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 ]
  2. Maximal Observed Plasma Concentration (Cmax) [ Time Frame: 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 ]
  3. Area Under the Plasma Concentration-Time Curve From Zero to Time t (AUC0-t) [ Time Frame: 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 ]
  4. Apparent Terminal Elimination Half-Life (t½) [ Time Frame: 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 ]
  5. Systemic Clearance (CL), Defined as Dose/AUC0-inf [ Time Frame: 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 ]
  6. Apparent Volume of Distribution (Vz) [ Time Frame: 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074459


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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United States, Florida
Labcorp Clinical Research Unit, Inc. Recruiting
Daytona Beach, Florida, United States, 32117
United States, Wisconsin
Labcorp Clinical Research Unit, Inc. Recruiting
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S H. Lundbeck A/S
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT05074459    
Other Study ID Numbers: 19889A
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No