NCT04564066 is a Phase 1 clinical trial of efgartigimod IV in Healthy Volunteers, sponsored by argenx.

Who is sponsoring NCT04564066?

NCT04564066 is sponsored by argenx.

What drugs are being tested in NCT04564066?

Interventions in NCT04564066: efgartigimod IV, efgartigimod PH20 SC.

What condition does NCT04564066 study?

NCT04564066 studies Healthy Volunteers.

Is NCT04564066 still recruiting?

NCT04564066 is currently completed. Last updated 5 April 2021.

Last reviewed 2021-04-05 · How we verify

NCT04564066

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

A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers

Completed Phase 1 Last updated 5 April 2021

What this trial tests

Phase 1 trial testing efgartigimod IV in Healthy Volunteers in 54 participants. Completed in 11 February 2021.

Timeline

18 August 2020

Primary endpoint
24 December 2020

11 February 2021

Quick facts

Lead sponsor	argenx
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	18 August 2020
Primary completion	24 December 2020
Estimated completion	11 February 2021
Sites	1 location across Netherlands

Drugs / interventions tested

efgartigimod IV — full drug profile →
efgartigimod PH20 SC — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

argenx — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.
Gjølberg TT, Mester S, Calamera G, Telstad JS, et al · · 2025 · cited 10× · PMID 40156757 · DOI 10.1007/s40259-025-00708-2

Verify or expand the search:

Other trials of efgartigimod IV

Trials testing the same drug.

NCT05810948 — A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013) · Phase 2 · completed
NCT05810961 — A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1 · Phase 2 · terminated
NCT04735432 — Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgarti · Phase 3 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other argenx trials

Trials by the same sponsor.

NCT07377396 — A Study to Assess the Safety of ARGX-124 in Healthy Volunteers · Phase 1 · recruiting
NCT07287982 — A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration · Phase 2 · recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With · Phase 2 · recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip · recruiting
NCT07091630 — A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP · Phase 3 · 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 NCT04564066 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by argenx
Last refreshed: 5 April 2021

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/NCT04564066.

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