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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2023-10-03

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.

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Detailed Description

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Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Blinded/unblinded site teams

Study Groups

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AVT05 50mg s.c.

Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Group Type EXPERIMENTAL

AVT05

Intervention Type BIOLOGICAL

Pre filled syringes filled with AVT05

EU Simponi 50mg s.c.

Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Group Type ACTIVE_COMPARATOR

Simponi

Intervention Type BIOLOGICAL

Pre filled syringes filled with Simponi

US Simponi 50mg s.c.

Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Group Type ACTIVE_COMPARATOR

Simponi

Intervention Type BIOLOGICAL

Pre filled syringes filled with Simponi

Interventions

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AVT05

Pre filled syringes filled with AVT05

Intervention Type BIOLOGICAL

Simponi

Pre filled syringes filled with Simponi

Intervention Type BIOLOGICAL

Other Intervention Names

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Golimumab

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes