Healthy Male and Female SubjectsPhase 1NCT06732804
Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
A Phase 1 study testing AVT80, Geographical region 1 Entyvio and Geographical region 2 Entyvio in people with Healthy Male and Female Subjects, run by Alvotech Swiss AG at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Subjects
- What is being tested?
- AVT80, Geographical region 1 Entyvio and Geographical region 2 Entyvio
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Feb 2025to 8 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
New Zealand2 sites
Investigational Site 0002
Auckland
NZCR
Christchurch, 8011
About this study
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
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.
Read the detailed description
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.
- Conditions
- Healthy Male and Female Subjects
- Being tested
- AVT80, Geographical region 1 Entyvio, Geographical region 2 Entyvio
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVT80Biological
Single subcutaneous injection of AVT80 (108mg)
Geographical region 1 EntyvioBiological
Single subcutaneous injection of Geographical region 1 Entyvio (108mg)
Geographical region 2 EntyvioBiological
Single subcutaneous injection of Geographical region 2 Entyvio (108mg)
| Study group | Role | What they receive |
|---|---|---|
| AVT80 | Experimental | Single subcutaneous administration of AVT80 Receives: Biological: AVT80 |
| Geographical region 1 Entyvio | Active comparator | Single subcutaneous administration of Geographical region 1 Entyvio Receives: Biological: Geographical region 1 Entyvio |
| Geographical region 2 Entyvio | Active comparator | Single subcutaneous administration of Geographical region 2 Entyvio Receives: Biological: Geographical region 2 Entyvio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
PK endpoint of Cmax.
Measured: Day Zero to Day 126
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
PK endpoint of AUC0-inf.
Measured: Day Zero to Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start11 Feb 2025
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eveline Schurink, Study director, Alvotech Swiss AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732804
- Sponsor's protocol ID
- AVT80-GL-P01
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06732804
- Acronym / sponsor ID
- AVT80-GL-P01
- Conditions
- Healthy Male and Female Subjects
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AVT80 | Experimental | Biological: AVT80Single subcutaneous administration of AVT80 |
| Geographical region 1 Entyvio | Active comparator | Biological: Geographical region 1 EntyvioSingle subcutaneous administration of Geographical region 1 Entyvio |
| Geographical region 2 Entyvio | Active comparator | Biological: Geographical region 2 EntyvioSingle subcutaneous administration of Geographical region 2 Entyvio |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVT80Single subcutaneous injection of AVT80 (108mg) | Biological | AVT80 |
| Geographical region 1 EntyvioSingle subcutaneous injection of Geographical region 1 Entyvio (108mg) | Biological | Geographical region 1 Entyvio |
| Geographical region 2 EntyvioSingle subcutaneous injection of Geographical region 2 Entyvio (108mg) | Biological | Geographical region 2 Entyvio |
Primary outcome
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
Time frame: 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
Time frame: Day Zero to Day 126
PK endpoint of AUC0-inf.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eveline Schurink study director
Alvotech Swiss AG
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVT80, Geographical region 1 Entyvio and Geographical region 2 Entyvio in people with Healthy Male and Female Subjects, run by Alvotech Swiss AG at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day Zero to Day 126). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.