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

Alvotech

Status and phase: Completed; Phase 1

Conditions: Healthy Male and Female Subjects

Treatments: Biological: AVT80; Biological: Geographical region 2 Entyvio; Biological: Geographical region 1 Entyvio

Study type: Interventional

Funder types: Industry

Identifiers

NCT06732804

AVT80-GL-P01

Details and patient eligibility

About

The study has been designed as a randomised, parallel-group, double-blind, 3 arm study to investigate the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio in healthy volunteers.

Full description

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.

Enrollment: 385 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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385 participants in 3 patient groups

AVT80

Experimental group

Description:

Single subcutaneous administration of AVT80

Treatment:

Biological: AVT80

Geographical region 1 Entyvio

Active Comparator group

Description:

Single subcutaneous administration of Geographical region 1 Entyvio

Treatment:

Biological: Geographical region 1 Entyvio

Geographical region 2 Entyvio

Active Comparator group

Description:

Single subcutaneous administration of Geographical region 2 Entyvio

Treatment:

Biological: Geographical region 2 Entyvio