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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03983876




Registration number
NCT03983876
Ethics application status
Date submitted
10/06/2019
Date registered
12/06/2019

Titles & IDs
Public title
PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
Scientific title
Multi-center, Randomized, Open-Label, 2-Arm Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of AVT02 Administered Subcutaneously Via Prefilled Syringe or Autoinjector in Healthy Adult Volunteers (ALVOPAD PEN)
Secondary ID [1] 0 0
AVT02-GL-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phase 1 0 0
Condition category
Condition code

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

Experimental: AVT02 100mg/mL in PFS - Prefilled Syringe Arm

Experimental: AVT02 100mg/mL in Autoinjector - Autoinjector Arm


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 disease
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
Area under the plasma concentration-time curve AUC0-inf
Timepoint [2] 0 0
From baseline to day 64
Primary outcome [3] 0 0
Maximum serum concentration
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 day 64
Secondary outcome [2] 0 0
Anti Drug Antibodies (ADRs)
Timepoint [2] 0 0
From baseline to day 64
Secondary outcome [3] 0 0
Adverse Events
Timepoint [3] 0 0
Baseline to day 84

Eligibility
Key inclusion criteria
To be eligible for study entry, subjects must satisfy all of the following 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: 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 (BP) of =150 mmHg and diastolic BP 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;
* Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;
* Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;
* Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;
* Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;
* Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
To be eligible for study entry, subjects must satisfy all of the following 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: 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 (BP) of =150 mmHg and diastolic BP 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;
* Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;
* Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;
* Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;
* Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;
* Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;

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
Open (masking not used)
Who is / are masked / blinded?



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
1/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2019
Sample size
Target
Accrual to date
Final
207
Recruitment in Australia
Recruitment state(s)
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
Address 0 0
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/NCT03983876