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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06400719
Registration number
NCT06400719
Ethics application status
Date submitted
24/04/2024
Date registered
6/05/2024
Date last updated
31/05/2024
Titles & IDs
Public title
Pilot Study of AVT16 in Healthy Adult Subjects
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Scientific 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
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Secondary ID [1]
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AVT16-GL-F01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - AVT16
Experimental: AVT16 - Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab
Other interventions: AVT16
Single intravenous administration of 300mg of AVT16
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence, nature and severity of Treatment Emergent Adverse Events
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Assessment method [1]
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Safety and Tolerability of AVT16
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Timepoint [1]
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18 weeks
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Secondary outcome [1]
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Maximum Plasma Concentration (Cmax) of AVT16
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Assessment method [1]
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Pharmacokinetic parameters
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Timepoint [1]
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18 weeks
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Secondary outcome [2]
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Frequency of anti-drug antibodies
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Assessment method [2]
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Immunogenicity of AVT16
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Timepoint [2]
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18 weeks
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Eligibility
Key inclusion criteria
- 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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
16/10/2024
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Actual
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Sample size
Target
18
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alvotech Swiss AG
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06400719
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Richard Bucknall
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Address
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Country
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Phone
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0041786598989
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06400719
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