NCT06732804

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2025

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 11, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 10, 2024

Last Update Submit

January 16, 2026

Conditions

Healthy Male and Female Subjects

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (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

    PK endpoint of Cmax.

    Day Zero to Day 126

  • 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

    PK endpoint of AUC0-inf.

    Day Zero to Day 126

Study Arms (3)

AVT80

EXPERIMENTAL

Single subcutaneous administration of AVT80

Biological: AVT80

Geographical region 1 Entyvio

ACTIVE COMPARATOR

Single subcutaneous administration of Geographical region 1 Entyvio

Biological: Geographical region 1 Entyvio

Geographical region 2 Entyvio

ACTIVE COMPARATOR

Single subcutaneous administration of Geographical region 2 Entyvio

Biological: Geographical region 2 Entyvio

Interventions

AVT80BIOLOGICAL

Single subcutaneous injection of AVT80 (108mg)

AVT80
Geographical region 1 EntyvioBIOLOGICAL

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

Geographical region 1 Entyvio
Geographical region 2 EntyvioBIOLOGICAL

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

Geographical region 2 Entyvio

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Veritus Research Pty Ltd

Bayswater, Australia

Location

Investigational Site 0002

Auckland, New Zealand

Location

NZCR

Christchurch, 8011, New Zealand

Location

Study Officials

  • Eveline Schurink

    Alvotech Swiss AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 13, 2024

Study Start

February 11, 2025

Primary Completion

January 8, 2026

Study Completion

January 8, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NZ(2)AU(1)