HealthyPhase 1NCT06400719
Pilot Study of AVT16 in Healthy Adult Subjects
A Phase 1 study testing AVT16 in people with Healthy, run by Alvotech Swiss AG at 1 site in New Zealand.
Trial summary
This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AVT16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNew Zealand
- Study dates
- 29 May 2024to 6 Nov 2024
- 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 subjects aged between 18 and 55 years old inclusive
- Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety
- Haematology and biochemistry tests within normal range
Who cannot join
- History of relevant drug and/or food allergies
- History of hypersensitivity to vedolizumab, AVT16 of their constituents
- Past or concurrent medical conditions that could potentially increase subject's risks or interfere with study evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive
This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.
- Conditions
- Healthy
- Being tested
- AVT16
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVT16Biological
Single intravenous administration of 300mg of AVT16
| Study group | Role | What they receive |
|---|---|---|
| AVT16 | Experimental | Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab Receives: Biological: AVT16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature and severity of Treatment Emergent Adverse Events
Safety and Tolerability of AVT16
Measured: 18 weeks
Secondary outcomes (2)
Maximum Plasma Concentration (Cmax) of AVT16
Pharmacokinetic parameters
Measured: 18 weeks
Frequency of anti-drug antibodies
Immunogenicity of AVT16
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start29 May 2024
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400719
- Sponsor's protocol ID
- AVT16-GL-F01
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive
- ClinicalTrials.gov ID
- NCT06400719
- Acronym / sponsor ID
- AVT16-GL-F01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 6 May 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.
This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVT16 | Experimental | Biological: AVT16Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab |
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 subjects aged between 18 and 55 years old inclusive
- Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety
- Haematology and biochemistry tests within normal range
Key exclusion criteria (3 listed)
- History of relevant drug and/or food allergies
- History of hypersensitivity to vedolizumab, AVT16 of their constituents
- Past or concurrent medical conditions that could potentially increase subject's risks or interfere with study evaluations
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 |
|---|---|---|
| AVT16Single intravenous administration of 300mg of AVT16 | Biological | AVT16 |
Primary outcome
Incidence, nature and severity of Treatment Emergent Adverse Events
Time frame: 18 weeks
Safety and Tolerability of AVT16
2 secondary outcomes
Maximum Plasma Concentration (Cmax) of AVT16
Time frame: 18 weeks
Frequency of anti-drug antibodies
Time frame: 18 weeks
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 11 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVT16 in people with Healthy, run by Alvotech Swiss AG at 1 site in New Zealand.
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 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. 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?
Incidence, nature and severity of Treatment Emergent Adverse Events (time frame: 18 weeks). 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 11 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.