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

August 25, 2022 updated by: H. Lundbeck A/S

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Labcorp Clinical Research Unit, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Labcorp Clinical Research Unit, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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)
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
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)
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
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)
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
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
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
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 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19889A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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