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

Healthy Adult Subjects Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05632211
• Other study ID #: AVT05-GL-P01
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2022
• Est. completion date: October 3, 2023

Study information

• Verified date: October 2023
• Source: Alvotech Swiss AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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-a inhibitors including golimumab.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Biological:
• AVT05
Pre filled syringes filled with AVT05
• Simponi
Pre filled syringes filled with Simponi

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Christchurch
United Kingdom	Richmond Pharmacology Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Alvotech Swiss AG	Iqvia Pty Ltd

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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