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

Alvotech

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Biological: Simponi; Biological: AVT05

Study type: Interventional

Funder types: Industry

Identifiers

NCT05632211

AVT05-GL-P01

Details and patient eligibility

About

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.

Enrollment: 336 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 3 patient groups

AVT05 50mg s.c.

Experimental group

Description:

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

Treatment:

Biological: AVT05

EU Simponi 50mg s.c.

Active Comparator group

Description:

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

Treatment:

Biological: Simponi

US Simponi 50mg s.c.

Active Comparator group

Description:

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

Treatment:

Biological: Simponi