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OpenTrials
Completed

NCT Number: NCT06732804

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Veritus Research Pty Ltd, Bayswater, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

  1. 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

    Time frame: Day Zero to Day 126

    PK endpoint of Cmax.

  2. 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

    Time frame: Day Zero to Day 126

    PK endpoint of AUC0-inf.

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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