A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

NCT05632211 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AVT05-GL-P01
• Study Type: interventional
• Target: 336
• Locations: 2 countries
• Sites: 2

Brief Summary

Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (2)

• To Demonstrate the PK Similarity of AVT05 With US Licensed and EU Approved Simponi and the PK of EU Approved Simponi With US Licensed Simponi

  The primary PK parameters to be compared is Cmax and AUC0-inf.

  Day zero to day 75 - days 1 (within the hour prior to dosing and at 8 and 12 hours post-dose), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 22, 29, 36, 43, 50, 57, 64, and 75.

• To Demonstrate the PK Similarity of AVT05 With US Licensed and EU Approved Simponi and the PK of EU Approved Simponi With US Licensed Simponi

  The primary PK parameter to be compared is AUC0-inf

  Day zero to day 75 - days 1 (within the hour prior to dosing and at 8 and 12 hours post-dose), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 22, 29, 36, 43, 50, 57, 64, and 75.

Study Arms (3)

AVT05 50mg s.c.

EXPERIMENTAL

Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Biological: AVT05

EU Simponi 50mg s.c.

ACTIVE COMPARATOR

Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Biological: Simponi

US Simponi 50mg s.c.

ACTIVE COMPARATOR

Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Biological: Simponi

Interventions

AVT05 BIOLOGICAL

Pre filled syringes filled with AVT05

AVT05 50mg s.c.

Simponi BIOLOGICAL

Pre filled syringes filled with Simponi

Also known as: Golimumab

EU Simponi 50mg s.c.; US Simponi 50mg s.c.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
• Participants must be 18 to 55 years old (inclusive) at the time of signing the ICF.
• Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive).

You may not qualify if:

• Have a history of relevant drug and/or food allergies.
• Known or suspected clinically relevant drug hypersensitivity to golimumab, AVT05, or any of its constituents, which in the opinion of the PI, contraindicates the participant's participation.
• Have any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (eg, malignancies or demyelinating disorders).
• Previous exposure to other TNF-α inhibitors including golimumab.

Sponsors & Collaborators

• Alvotech Swiss AG: lead
• Iqvia Pty Ltd: collaborator

Study Sites (2)

New Zealand Clinical Research

Christchurch, 8011, New Zealand

Location

Richmond Pharmacology Ltd

London, United Kingdom

Location

Related Publications (1)

• Wynne C, Lorch U, Krantz E, Katial R, Ashdown T, Luque M, Sattar A, Rai M, Vashishta L, Petrovic K, Ruffieux R, Leutz S, Berti F. Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study. BioDrugs. 2026 Jan;40(1):121-133. doi: 10.1007/s40259-025-00749-7. Epub 2025 Nov 10.

  PMID: 41212475 DERIVED

MeSH Terms

Interventions

golimumab

Results Point of Contact

• Title: Clinical Development and Medical Lead
• Organization: Alvotech Swiss AG

alvotech.clinical@alvotech.com

+41 78 659 89 89

Study Officials

• Chris Wynne

  New Zealand Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinded/unblinded site teams
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 30, 2022
• Study Start: December 16, 2022
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); GB (1)