drugset / Trial / NCT06732804
Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2025-02-11
- Primary completion
- 2026-01-08
- Completion
- 2026-01-08
Outcome
Met primary endpoint
release “The PK study (AVT80-GL-P01), which compared AVT80 to Entyvio in healthy adult participants, met all its primary endpoints.” alvotech.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AVT80 | Unknown | 108 mg | Subcutaneous |
| Comparator | Vedolizumab | Monoclonal antibody | 108 mg | Subcutaneous |
Indications
No indication recorded.