AVT80
BiologicalSingle subcutaneous injection of AVT80 (108mg)
NCT Number: NCT06732804
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Veritus Research Pty Ltd, Bayswater, Australia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single subcutaneous injection of AVT80 (108mg)
Single subcutaneous injection of Geographical region 1 Entyvio (108mg)
Single subcutaneous injection of Geographical region 2 Entyvio (108mg)
Time frame: Day Zero to Day 126
PK endpoint of Cmax.
Time frame: Day Zero to Day 126
PK endpoint of AUC0-inf.
Alvotech Swiss AG
Industry
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
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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