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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Biological: AVT05
* Biological: Simponi


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |