Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio

The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to receive a single dose of either AVT80, geographical region 1 Entyvio or geographical region 2 Entyvio.

• AVT80 (Biological): Single subcutaneous injection of AVT80 (108mg)
• Geographical region 1 Entyvio (Biological): Single subcutaneous injection of Geographical region 1 Entyvio (108mg)
• Geographical region 2 Entyvio (Biological): Single subcutaneous injection of Geographical region 2 Entyvio (108mg)

Primary outcomes

• To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio [Day Zero to Day 126]: PK endpoint of Cmax.
• To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio [Day Zero to Day 126]: PK endpoint of AUC0-inf.

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy male and female participant 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.
* Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to 32.0 kg/m2 (inclusive).
* Participant must be 18 to 55 years old inclusive, at the time of signing the ICF.

Exclusion Criteria:

* Participant has a history of relevant drug and/or food allergies.
* Participant has a history of hypersensitivity to Entyvio, AVT80, or their constituents.
* Participant has 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 (e.g., demyelinating disorders).

• Eveline Schurink, Study director, Alvotech Swiss AG