NCT06732804

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male and Female Subjects

Interventions

Type	Name	Description
BIOLOGICAL	AVT80	Single subcutaneous injection of AVT80 (108mg)
BIOLOGICAL	Geographical region 1 Entyvio	Single subcutaneous injection of Geographical region 1 Entyvio (108mg)
BIOLOGICAL	Geographical region 2 Entyvio	Single subcutaneous injection of Geographical region 2 Entyvio (108mg)

Timeline

• Start date: 2025-02-11
• Primary completion: 2026-01-08
• Completion: 2026-01-08
• First posted: 2024-12-13
• Last updated: 2026-01-20

Locations

3 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study