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

A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06732804

Enrollment

385

Registered

2024-12-13

Start date

2025-02-11

Completion date

2026-01-08

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male and Female Subjects

Keywords

Pharmacokinetics

Brief summary

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.

Detailed 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.

Interventions

BIOLOGICALAVT80

Single subcutaneous injection of AVT80 (108mg)

BIOLOGICALGeographical region 1 Entyvio

Single subcutaneous injection of Geographical region 1 Entyvio (108mg)

BIOLOGICALGeographical region 2 Entyvio

Single subcutaneous injection of Geographical region 2 Entyvio (108mg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Australia, New Zealand

Contacts

STUDY_DIRECTOREveline Schurink

Alvotech Swiss AG

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026