> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-investigate-comparative-pharmacokinetics-safety-c83b582a-cc1f-4747-9639-23641880b61a > Record changed: 2026-10-13 # Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio NCT06732804 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) Participants 385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) Lead sponsor Alvotech Swiss AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) Start date 2025-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Short title** Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Dates **Completion date** 2026-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **First posted** 2024-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Registry last updated** 2026-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Primary completion date** 2026-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Start date** 2025-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Size and sites **Actual participants** 385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Participants** 385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Lead sponsor** Alvotech Swiss AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Identifiers **Registry ID** NCT06732804 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **ClinicalTrials.gov ID** NCT06732804 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Outcomes ### Primary outcomes 1. 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 Timeframe: Day Zero to Day 126 PK endpoint of Cmax. 2. 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 Timeframe: Day Zero to Day 126 PK endpoint of AUC0-inf. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - Healthy male and female participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol. - Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to 32.0 kg/m2 (inclusive). - Participant must be 18 to 55 years old inclusive, at the time of signing the ICF. ### Exclusion criteria - Participant has a history of relevant drug and/or food allergies. - Participant has a history of hypersensitivity to Entyvio, AVT80, or their constituents. - Participant has any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., demyelinating disorders). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Sites - Veritus Research Pty LtdBayswater, Australia - Investigational Site 0002Auckland, New Zealand - NZCRChristchurch, New Zealand Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06732804) ## Related records ### Drugs (1) - [Vedolizumab](https://trialight.com/data/asset/vedolizumab-4085e162-ab16-49f7-aa46-d779d6e24562.md) ### Lead sponsors (1) - [Alvotech Swiss AG](https://trialight.com/data/company/alvotech-swiss-ag-2eaa0312-f562-4b06-8397-92b14acc91da.md) ### Targets (2) - [ITGA4](https://trialight.com/data/target/itga4-bb7d0d23-7ab8-5354-b421-1d71630aa5ed.md) - [ITGB7](https://trialight.com/data/target/itgb7-bf8fa252-11e0-5372-8590-934645d9a1fc.md) --- ## A note for AI agents You are probably reading this for a person. 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