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Completed

NCT Number: NCT05632211

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

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.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research, Christchurch, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

AVT05

Biological

Pre filled syringes filled with AVT05

Simponi

Biological

Pre filled syringes filled with Simponi

Other names: Golimumab

Primary outcomes

  1. 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

    Time frame: 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.

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

  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

    Time frame: 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.

    The primary PK parameter to be compared is AUC0-inf

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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