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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03849313




Registration number
NCT03849313
Ethics application status
Date submitted
4/02/2019
Date registered
21/02/2019

Titles & IDs
Public title
Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)
Scientific title
Multicentre, Randomized, Double-Blind, 3-Arm, Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of AVT02 to EU-approved and US-licensed Humira® Administered as a Single Dose (40 mg Subcutaneous Injection) in Healthy Adult Volunteers (ALVOPA D FIRST)
Secondary ID [1] 0 0
AVT02-GL-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Adalimumab

Experimental: AVT02 100mg/mL - Biosimilar Adalimumab AVT02

Active comparator: EU-Humira 100mg/mL - EU Approved Adalimumab originator Humira

Active comparator: US-Humira 100mg/mL - US licensed Adalimumab originator Humira


Treatment: Drugs: Adalimumab
AVT02, a proposed similar biological product (biosimilar) of Humira which contains adalimumab . Adalimumab is a recombinant, fully human monoclonal immunoglobulin G1 (IgG1) antibody that binds specifically and with high affinity to the soluble and transmembrane forms of tumor necrosis factor (TNF)-a thereby inhibiting the binding of TNF-a with its receptor, and inhibiting TNF -a's biological function.

Tumor necrosis factor-a is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-a are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients and psoriasis plaques and play an important role in both the pathologic inflammation and joint destruction that are hallmarks of these inflammatory diseases
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the plasma concentration-time curve AUC0-t
Timepoint [1] 0 0
From baseline to day 64
Primary outcome [2] 0 0
Maximum serum concentration
Timepoint [2] 0 0
From baseline to day 64
Primary outcome [3] 0 0
Area under the plasma concentration-time curve AUC0-inf
Timepoint [3] 0 0
From baseline to day 64
Secondary outcome [1] 0 0
Pain, Tenderness, Erythema and Swelling
Timepoint [1] 0 0
From baseline to over a 64 day period
Secondary outcome [2] 0 0
Anti Drug Antibodies (ADRs)
Timepoint [2] 0 0
Baseline to over a 64 day period
Secondary outcome [3] 0 0
Adverse Events
Timepoint [3] 0 0
From screening to day 64.
Secondary outcome [4] 0 0
Neutralizing Antibodies (NAbs)
Timepoint [4] 0 0
From screening to day 64.

Eligibility
Key inclusion criteria
* Male or female healthy adult subjects willing to sign a patient information and consent form (PICF) and able to undergo protocol related procedures.
* Age: 18 to 55 years, inclusive.
* Body Mass Index (BMI): 18.5 to 32.0 kg/m2.
* No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety.
* Resting supine systolic blood pressure of =150 mmHg and diastolic blood pressure of =90 mmHg. Other vital signs showing no clinically relevant deviations according to the investigator's judgment.
* 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator.
* Negative urine drug screen and negative alcohol breath test at screening and admission.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

* Subjects will be excluded from the study if one or more of the following criterion are applicable:
* Evidence of clinically relevant pathology
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) used in study.
* Known history of previous exposure to adalimumab or other anti TNF-alpha molecules.
* Subjects with a recent (within 6 months of dosing) infection requiring hospitalisation or intravenous antibiotic use.
* Subjects with a recent (within 4 weeks of dosing) infection requiring oral or systemic antibiotics.
* Subject with a history of recurrent or chronic infections.
* Subject has a positive test for tuberculosis (TB) during screening or a known history of active or latent TB, except documented and complete adequate treatment of TB.
* Having received live vaccines during the 4 weeks before screening or have the intention to receive vaccination during the study.
* Participation in a drug study within 60 days or 5 half-lives of the previous drug (if known), whichever is longer, prior to drug administration Note: Only the few inclusion/exclusion criteria are mentioned here. Subjects will be screened and randomized as per the full list of inclusion and exclusion criteria in the protocol.

Study design
Purpose of the study
Other
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 administering the treatment/s
The people assessing the outcomes
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
20/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2020
Sample size
Target
Accrual to date
Final
390
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Chistchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

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
Christian Schwabe
Address 0 0
Auckland Clinical Studies Limited
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

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/NCT03849313