Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
NCT06732804
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Alvotech Swiss AG
Start date
2025-02-11
Number of sites
- 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.
- Short title
- Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-01-08
- First posted
- 2024-12-13
- Registry last updated
- 2026-01-20
- Primary completion date
- 2026-01-08
- Start date
- 2025-02-11
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Alvotech Swiss AG
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06732804
- ClinicalTrials.gov ID
- NCT06732804
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
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.
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
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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
- Veritus Research Pty LtdBayswater, Australia
- Investigational Site 0002Auckland, New Zealand
- NZCRChristchurch, New Zealand
Sources for sites