Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06400719




Registration number
NCT06400719
Ethics application status
Date submitted
24/04/2024
Date registered
6/05/2024
Date last updated
28/06/2024

Titles & IDs
Public title
Pilot Study of AVT16 in Healthy Adult Subjects
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
Secondary ID [1] 0 0
AVT16-GL-F01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - AVT16

Experimental: AVT16 - Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab


Treatment: Other: AVT16
Single intravenous administration of 300mg of AVT16
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, nature and severity of Treatment Emergent Adverse Events
Timepoint [1] 0 0
18 weeks
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) of AVT16
Timepoint [1] 0 0
18 weeks
Secondary outcome [2] 0 0
Frequency of anti-drug antibodies
Timepoint [2] 0 0
18 weeks

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/10/2024
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alvotech Swiss AG
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06400719
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Richard Bucknall
Address 0 0
Country 0 0
Phone 0 0
0041786598989
Fax 0 0
Email 0 0
richard.bucknall@alvotech.com
Contact person for scientific queries