PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)

NCT03983876 | Completed Phase 1

• 1 other identifier: AVT02-GL-102
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 2

Brief Summary

This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of 40mg of AVT02 (Adalimumab)

Conditions

Phase 1

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve AUC0-t

  Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector

  From baseline to day 64

• Area under the plasma concentration-time curve AUC0-inf

  Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector

  From baseline to day 64

• Maximum serum concentration

  Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector

  From baseline to day 64

Secondary Outcomes (3)

• Pain, Tenderness, Erythema and Swelling

  From baseline to day 64

• Anti Drug Antibodies (ADRs)

  From baseline to day 64

• Adverse Events

  Baseline to day 84

Study Arms (2)

AVT02 100mg/mL in PFS

EXPERIMENTAL

Prefilled Syringe Arm

Drug: Adalimumab

AVT02 100mg/mL in Autoinjector

EXPERIMENTAL

Autoinjector Arm

Drug: Adalimumab

Interventions

Adalimumab DRUG

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)-α thereby inhibiting the binding of TNF-α with its receptor, and inhibiting TNF -α's biological function. Tumor necrosis factor-α is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-α 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

Also known as: Humira ATC code L04AB0

AVT02 100mg/mL in Autoinjector; AVT02 100mg/mL in PFS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (2)

Christchurch Clinical Studies Trust Limited

Christchurch, Chistchurch, 8011, New Zealand

Location

Auckland Clinical Studies

Auckland, New Zealand

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, 2-arm parallel study of AVT02 (Administered via a PFS either manually via an autoinjector, in healthy adult subjects. The subjects in both arms will receive the same dose of AVT02, but in two different delivery modes.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: July 1, 2019
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)