Lead Sponsor

Alvotech Swiss AG

Collaborators

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

•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).

•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.

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