NCT03983876 is a Phase 1 clinical trial of Adalimumab in Phase 1, sponsored by Alvotech Swiss AG.

Who is sponsoring NCT03983876?

NCT03983876 is sponsored by Alvotech Swiss AG.

What drugs are being tested in NCT03983876?

Interventions in NCT03983876: Adalimumab.

Is NCT03983876 still recruiting?

NCT03983876 is currently completed. Last updated 4 May 2022.

Last reviewed 2022-05-04 · How we verify

NCT03983876

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

PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)

Completed Phase 1 Last updated 4 May 2022

What this trial tests

Phase 1 trial testing Adalimumab in Phase 1 in 207 participants. Completed in 3 December 2019.

Timeline

1 July 2019

Primary endpoint
3 December 2019

3 December 2019

Quick facts

Lead sponsor	Alvotech Swiss AG
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	207
Start date	1 July 2019
Primary completion	3 December 2019
Estimated completion	3 December 2019
Sites	2 locations across New Zealand

Drugs / interventions tested

Adalimumab (ADALIMUMAB) — full drug profile →

Conditions studied

Phase 1 — all drugs for Phase 1 →

Sponsor

Alvotech Swiss AG — full company profile →

Who can join

Adults 18 to 55, any sex, with Phase 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of 40mg of AVT02 (Adalimumab)

Publications & conference data

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

The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira.
McClellan JE, Ómarsdóttir S, Roy N, Berger V, et al · · 2024 · cited 2× · PMID 38250743 · DOI 10.1177/20406223231223286

Verify or expand the search:

Other trials of Adalimumab

Trials testing the same drug.

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NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting

Other recruiting trials for Phase 1

Currently open trials in the same condition.

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NCT07072234 — Phase I Study of Allogeneic Transforming Growth Factor-beta Receptor Type 2 Knockout CD70 CAR NK Cells in Treatment Refr · Phase 1 · recruiting
NCT06660420 — Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recu · Phase 1 · recruiting

Other Alvotech Swiss AG trials

Trials by the same sponsor.

NCT06732804 — Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio · Phase 1 · completed
NCT06570772 — Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio · Phase 3 · terminated
NCT06400719 — Pilot Study of AVT16 in Healthy Adult Subjects · Phase 1 · completed
NCT05986786 — Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease · Phase 3 · completed
NCT05876949 — AVT03 With Xgeva in Healthy Male Subjects · Phase 1 · completed

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 NCT03983876 (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 Alvotech Swiss AG
Last refreshed: 4 May 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/NCT03983876.

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