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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Biological: AVT05; Biological: Simponi

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Richard Bucknall; Phone Number: 00447415781856; Email: richard.bucknall@alvotech.com
• Study Contact Backup: Name: Katarina Petrovic; Email: katarina.petrovic@alvotech.com

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • New Zealand Clinical Research
    • Contact: Chris Wynne
• United Kingdom
  • London, United Kingdom
    • Richmond Pharmacology Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVT05 50mg s.c.; Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen	Biological: AVT05; Pre filled syringes filled with AVT05
Active Comparator: EU Simponi 50mg s.c.; Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen	Biological: Simponi; Pre filled syringes filled with Simponi; Other Names: Golimumab
Active Comparator: US Simponi 50mg s.c.; Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen	Biological: Simponi; Pre filled syringes filled with Simponi; Other Names: Golimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Cmax	Day zero to day 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

Collaborators and Investigators

• Sponsor: Alvotech Swiss AG
• Collaborators: Iqvia Pty Ltd
• Investigators: Principal Investigator: Chris Wynne, New Zealand Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: AVT05-GL-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes