NCT05074459 is a Phase 1 clinical trial of Eptinezumab Mammalian Cell Line in Healthy Participants, sponsored by H. Lundbeck A/S.

Who is sponsoring NCT05074459?

NCT05074459 is sponsored by H. Lundbeck A/S.

What drugs are being tested in NCT05074459?

Interventions in NCT05074459: Eptinezumab Mammalian Cell Line, Eptinezumab Yeast Cell Line.

What condition does NCT05074459 study?

NCT05074459 studies Healthy Participants.

Is NCT05074459 still recruiting?

NCT05074459 is currently completed. Last updated 29 August 2022.

Last reviewed 2022-08-29 · How we verify

NCT05074459

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 29 August 2022

What this trial tests

Phase 1 trial testing Eptinezumab Mammalian Cell Line in Healthy Participants in 84 participants. Completed in 18 July 2022.

Timeline

27 September 2021

Primary endpoint
18 July 2022

18 July 2022

Quick facts

Lead sponsor	H. Lundbeck A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	84
Start date	27 September 2021
Primary completion	18 July 2022
Estimated completion	18 July 2022
Sites	2 locations across United States

Drugs / interventions tested

Eptinezumab Mammalian Cell Line — full drug profile →
Eptinezumab Yeast Cell Line — full drug profile →

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

H. Lundbeck A/S — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy Participants

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NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting

Other H. Lundbeck A/S trials

Trials by the same sponsor.

NCT07514858 — A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations · Phase 2 · not yet recruiting
NCT07513441 — A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) · Phase 1 · not yet recruiting
NCT06701526 — A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications · Phase 4 · active not recruiting
NCT06706622 — A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) · Phase 3 · active not recruiting
NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05074459 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lundbeck A/S
Last refreshed: 29 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05074459.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing