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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
385
Single subcutaneous injection of AVT80 (108mg)
Single subcutaneous injection of Geographical region 1 Entyvio (108mg)
Single subcutaneous injection of Geographical region 2 Entyvio (108mg)
Veritus Research Pty Ltd
Bayswater, Australia
Investigational Site 0002
Auckland, New Zealand
NZCR
Christchurch, New Zealand
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.
Time frame: 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.
Time frame: Day Zero to Day 126
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