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

Phase 1

Recruiting

• Conditions: Healthy Male and Female Subjects
• Interventions: Biological: AVT80; Biological: Geographical region 2 Entyvio; Biological: Geographical region 1 Entyvio

• Registration Number: NCT06732804
• Lead Sponsor: Alvotech Swiss AG

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.

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-13
• Study Start: 2025-02-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 351

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVT80	AVT80	Single subcutaneous administration of AVT80
Geographical region 2 Entyvio	Geographical region 2 Entyvio	Single subcutaneous administration of Geographical region 2 Entyvio
Geographical region 1 Entyvio	Geographical region 1 Entyvio	Single subcutaneous administration of Geographical region 1 Entyvio

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Veritus Research Pty Ltd; 🇦🇺 Bayswater, Australia

Investigational Site 0002; 🇳🇿 Auckland, New Zealand

NZCR; 🇳🇿 Christchurch, New Zealand