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NCT05817435
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
Phase 1 trial testing efgartigimod PH20 SC as a prefilled syringe presentation in Bioequivalence in 120 participants. Completed in 12 May 2023.
12 May 2023
Quick facts
| Lead sponsor | argenx |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 120 |
| Start date | 13 March 2023 |
| Primary completion | 12 May 2023 |
| Estimated completion | 12 May 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- efgartigimod PH20 SC as a prefilled syringe presentation — full drug profile →
- efgartigimod PH20 SC as a vial + syringe presentation — full drug profile →
Conditions studied
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
argenx — full company profile →
Who can join
Adults 18 to 55, any sex, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.
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:
- PubMed search for NCT05817435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bioequivalence
Currently open trials in the same condition.
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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)
- Trial protocol + status: ClinicalTrials.gov NCT05817435 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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: 31 October 2023
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/NCT05817435.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing