A Clinical Study With Adalimumab Biosimilar

NCT06291948 | Completed Phase 1

• 1 other identifier: 0225
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) \[Test Product\] vs. Humira® AC Pen \[Reference Product\]

Conditions

Pharmacokinetics; Safety Issues

Keywords

adalimumab; Biosimilar; Rheumatoid arthritis; Bioequivalence; Immunogenicity; Safety; Enthesitis-related arthritis; Psoriatic arthritis; Ankylosing Spondylitis (AS); Non-radiographic axial spondyloarthritis; Crohn's disease; Plaque psoriasis; Ulcerative colitis; Hidradenitis suppurativa; Behcet's Intestinal Disease; Non-infectious uveitis; Adults, healthy, of both sexes

Outcome Measures

Primary Outcomes (3)

• Peak Serum Concentration of adalimumab (Cmax)

  Cmax will be obtained directly from the serum concentration-time curve

  Pre-dose: 0.00; Post-dose: 4.0; 8.0; 12.0; 24.0; 48.0; 72.0; 96.0; 120.0; 144.0; 168.0; 192.0; 336.0; 504.0; 672.0; 840.0; 1008.0; 1344.0; 1680.0 hours

• Area Under the Serum Concentration-time Curve of adalimumab (ABC0-t)

  Area under the serum concentration-time curve from time zero to the last experimental point, will be calculated by the trapezoidal rule

  Day 1 to Day 71

• Area Under the Serum Concentration- Time Curve ob adalimumab (ABC0-∞)

  Area under the serum concentration- time curve from time zero to infinity

  Day 1 to Day 71

Secondary Outcomes (1)

• Number of samples with positive Anti-adalimumab serum antibodies

  Screening, post dose: 672.0 hours, 1680.0 hours, 12 months

Other Outcomes (2)

• Adverse Events

  Day 1 to Day 71

• Number of positive Anti-adalimumab serum samples with neutralizing capacity

  Screening, post dose: 672.0 hours, 1680.0 hours, 12 months

Study Arms (2)

Humira® (adalimumab) AC Pen [Reference Product]

ACTIVE COMPARATOR

A single subcutaneous dose of 40 mg of the Reference Product- Humira® AC Pen \[Reference Product\]

Biological: Humira® (adalimumab) AC Pen [Reference Product]

Adalimumab Richmond [Test Product]

ACTIVE COMPARATOR

A single subcutaneous dose of 40 mg of the Test Product- Adalimumab Richmond \[Test Product\]

Biological: Adalimumab Richmond [Test Product]

Interventions

Humira® (adalimumab) AC Pen [Reference Product] BIOLOGICAL

A single subcutaneous dose

Humira® (adalimumab) AC Pen [Reference Product]

Adalimumab Richmond [Test Product] BIOLOGICAL

A single subcutaneous dose

Adalimumab Richmond [Test Product]

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written and signed informed consent
• Study subjects must be able to understand and comply with the protocol.
• Study subjects must be willing and able to provide written informed consent.
• Target population
• Study subjects, volunteers, adults, healthy.
• Study subjects with normal physical examination or with findings that, in the investigator's opinion, have no clinical relevance.
• Study subjects whose safety and complementary laboratory tests are within normal values or who, in the investigator's opinion, have no clinical relevance.
• Body mass index between 19 and 27 kg/m2 at the screening visit.
• Study subjects preferably non-smokers. Smokers must refrain from smoking during the clinical research protocol.
• Study subjects should not have a history of drug and/or alcohol abuse.
• Age and gender
• Women and men, from 21 to 55 years of age.
• Women must not be pregnant. Women must use adequate non-hormonal contraception to prevent pregnancy throughout the clinical investigation protocol \[and for a period of not less than 5 months after the last dose of the investigational product\].
• Men with a partner of childbearing potential must agree that their partner use adequate contraception prior to study entry \[and for a period of not less than 5 months after the last dose of investigational product\]. An adequate contraceptive method is understood to be any hormonal contraceptive method or intrauterine device (which must be established before the start of the study) and the use of a spermicide as a barrier method. Use of a barrier method alone or sexual abstinence is not considered appropriate.
• Subjects must agree not to donate sperm during the study and for 5 months after treatment.

You may not qualify if:

• Medical history and concurrent illnesses
• History of cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, endocrine-metabolic, neurological disease or conditions of psychiatric origin (depressive disorders, in particular) at the time of taking the history and physical examination during the first visit of the clinical research protocol.
• History of allergic drug reactions of any kind.
• History of orthostatic hypotension.
• Blood donation within 3 months prior to screening.
• Participation in another clinical pharmacology study in the last 3 months.
• History and/or current history of clinically significant diseases or disorders that, in the investigator's opinion, may prevent the participation of the study subject for safety reasons or that may influence the results of the study as well as the capacity of the study subject. to participate in the clinical research protocol.
• History of hypersensitivity to adalimumab and/or any of the excipients.
• Previous exposure to a biological product.
• Physical findings and laboratory tests
• Cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, endocrine-metabolic, neurological disease or conditions of psychiatric origin (depressive disorders, in particular).
• Clinically significant abnormalities in any laboratory tests
• Positive serology for HIV, hepatitis B, hepatitis C.
• Sex and reproductive condition
• \- Women of childbearing potential who are unwilling or unable to use an adequate non-hormonal method of contraception throughout the clinical investigation protocol \[and for a period of not less than 5 months after the last dose of the investigational product\].

Sponsors & Collaborators

• Laboratorios Richmond S.A.C.I.F.: lead
• FP Clinical Pharma S.R.L.: collaborator
• Custom Biologics: collaborator

Study Sites (1)

FP Clinical Pharma S.R.L.

Buenos Aires, C1425BAA, Argentina

Location

Related Publications (3)

• International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.

  PMID: 11590294 BACKGROUND

• Lembach J, Skerjanec A, Haliduola H, Hass N, von Richter O, Fuhr R, Koernicke T. Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects. Arthritis Rheumatol, 69(10), 2017

  BACKGROUND

• Wynne C, Altendorfer M, Sonderegger I, Gheyle L, Ellis-Pegler R, Buschke S, Lang B, Assudani D, Athalye S, Czeloth N. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE(R)-PK) in healthy subjects. Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370. doi: 10.1080/13543784.2016.1255724.

  PMID: 27813422 BACKGROUND

Related Links

• PubMed ID: 11590294
• A Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects.
• PubMed ID: 27813422

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Juvenile; Arthritis, Psoriatic; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ethel C. Feleder, MD

  FP Clinical Pharma S.R.L.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects, investigators, Sponsor, monitor, analytical center, and data analyst will be unaware of assigned treatments. Each product in its original primary packaging will be blinded and labeled with a fantasy name "Product A" or "Product B". The link between "Product A or B" with the Test Product or Reference Product will be kept in two separate copies in a sealed envelope. One copy will remain with the Sponsor and the other will be provided to the Principal Investigator. The envelope may only be opened in the event of a medical emergency. The investigator must follow the trial's randomization procedures, and must ensure that the code is broken only in accordance with the protocol. The investigator must promptly document and explain to the Sponsor should the identity of the investigational product be revealed (whether accidentally or due to a serious adverse event).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double Blind, Parallel groups, Phase 1 Clinical Study comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects.

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: March 4, 2024
• Study Start: August 1, 2022
• Primary Completion: January 10, 2023
• Study Completion: October 20, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)