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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06732804




Registration number
NCT06732804
Ethics application status
Date submitted
10/12/2024
Date registered
13/12/2024

Titles & IDs
Public title
Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
Scientific title
A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative Pharmacokinetics, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive
Secondary ID [1] 0 0
AVT80-GL-P01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Male and Female Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - AVT80
Treatment: Other - Geographical region 1 Entyvio
Treatment: Other - Geographical region 2 Entyvio

Experimental: AVT80 - Single subcutaneous administration of AVT80

Active comparator: Geographical region 1 Entyvio - Single subcutaneous administration of Geographical region 1 Entyvio

Active comparator: Geographical region 2 Entyvio - Single subcutaneous administration of Geographical region 2 Entyvio


Treatment: Other: AVT80
Single subcutaneous injection of AVT80 (108mg)

Treatment: Other: Geographical region 1 Entyvio
Single subcutaneous injection of Geographical region 1 Entyvio (108mg)

Treatment: Other: Geographical region 2 Entyvio
Single subcutaneous injection of Geographical region 2 Entyvio (108mg)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Day Zero to Day 126
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Day Zero to Day 126

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
351
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eveline Schurink
Address 0 0
Alvotech Swiss AG
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
+41 78 659 8989
Fax 0 0
Email 0 0
alvotech.clinical@alvotech.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06732804