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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/NCT05632211




Registration number
NCT05632211
Ethics application status
Date submitted
11/11/2022
Date registered
30/11/2022
Date last updated
11/10/2023

Titles & IDs
Public title
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Scientific title
A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants
Secondary ID [1] 0 0
AVT05-GL-P01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - AVT05
Other interventions - Simponi

Experimental: AVT05 50mg s.c. - Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Active Comparator: EU Simponi 50mg s.c. - Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen

Active Comparator: US Simponi 50mg s.c. - Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen


Other interventions: AVT05
Pre filled syringes filled with AVT05

Other interventions: Simponi
Pre filled syringes filled with Simponi
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate the PK similarity of AVT05 with US licensed and EU approved Simponi and the PK of EU approved Simponi with US licensed Simponi
Timepoint [1] 0 0
Day zero to day 75
Primary outcome [2] 0 0
To demonstrate the PK similarity of AVT05 with US licensed and EU approved Simponi and the PK of EU approved Simponi with US licensed Simponi
Timepoint [2] 0 0
Day zero to day 75

Eligibility
Key inclusion criteria
- Healthy participants 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.

- Participants must be 18 to 55 years old (inclusive) at the time of signing the ICF.

- Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 18.0 to
30.0 kg/m2 (inclusive).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Have a history of relevant drug and/or food allergies.

- Known or suspected clinically relevant drug hypersensitivity to golimumab, AVT05, or
any of its constituents, which in the opinion of the PI, contraindicates the
participant's participation.

- Have 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 (eg, malignancies or demyelinating disorders).

- Previous exposure to other TNF-a inhibitors including golimumab.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/10/2023
Sample size
Target
Accrual to date
Final
336
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alvotech Swiss AG
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Rationale:

Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product
Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study
with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed
biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed
Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as
a single 50 mg/0.5 mL SC dose.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05632211
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Wynne
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05632211