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Clinical trial

A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants

NCT05632211 is registered in ClinicalTrials.gov with Alvotech Swiss AG as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants
Lead sponsor
Alvotech Swiss AG
Phase
Phase 1
Overall status
Completed
Start date
December 16, 2022
Completion date
October 3, 2023
Enrollment
336 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

healthy adult subjects