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

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Biological: Simponi; Biological: AVT05

• Registration Number: NCT05632211
• Lead Sponsor: Alvotech Swiss AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-30
• Study Start: 2022-12-16
• Status Verified: 2023-10
• Primary Completion: 2023-10-03
• Study Completion: 2023-10-03
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US Simponi 50mg s.c.	Simponi	Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
AVT05 50mg s.c.	AVT05	Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen
EU Simponi 50mg s.c.	Simponi	Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Primary Outcome Measures

Name	Time	Method
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	Day zero to day 75	The primary PK parameter to be compared is AUC0-inf

Trial Locations

Locations (2)

Richmond Pharmacology Ltd; 🇬🇧 London, United Kingdom

New Zealand Clinical Research; 🇳🇿 Christchurch, New Zealand