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PharmacokineticsPhase 1NCT06291948

A Clinical Study With Adalimumab Biosimilar

A Phase 1 study testing Humira® (adalimumab) AC Pen [Reference Product] and Adalimumab Richmond [Test Product] in people with Pharmacokinetics and Safety Issues, run by Laboratorios Richmond S.A.C.I.F. at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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] Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics, Safety Issues
What is being tested?
Humira® (adalimumab) AC Pen [Reference Product] and Adalimumab Richmond [Test Product]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteArgentina
Study dates
1 Aug 2022to 20 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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].
  • Allergies, adverse drug reactions and contraindications
  • Study subjects with allergies, adverse drug reactions or contraindications to therapy.
  • Prohibited treatments and/or therapies
  • The study subjects must have suspended any drug treatments at least 2 weeks before starting this clinical research protocol.
  • Other exclusion criteria
  • Non-cooperative study subjects.
  • Study subjects employed by the investigator or the Clinical Pharmacokinetic Research Unit, with direct participation in the clinical investigation protocol or other clinical protocols under the direction of the Investigator or the Clinical Pharmacokinetic Research Unit.
  • The eligibility criteria for this clinical research protocol have been considered to guarantee the safety of the study subjects and ensure that their results can be used.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • FP Clinical Pharma S.R.L.

    Buenos Aires, C1425BAA

Other trials in Argentina

About this study

Official title: A Randomized, Double-blind, Parallel Groups, Phase 1 Clinical Study Comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects

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]

Read the detailed description

This is a phase 1 pharmacokinetic, safety and immunogenicity comparative, single-dose, double-blind, randomized, balanced parallel-group clinical study conducted in healthy subjects of both sexes.

Blood samples are collected for up to 71 days to determine the quantification of adalimumab and for 12 months for antidrug antibody detection. Safety and tolerability are also assessed.

Being tested
Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
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
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Juvenile, Arthritis, Psoriatic, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis, Crohn Disease, Colitis, Ulcerative, Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    A single subcutaneous dose

  • Adalimumab Richmond [Test Product]Biological

    A single subcutaneous dose

Study groups in NCT06291948
Study groupRoleWhat they receive
Humira® (adalimumab) AC Pen [Reference Product]Active comparatorA single subcutaneous dose of 40 mg of the Reference Product- Humira® AC Pen [Reference Product]
Receives: Biological: Humira® (adalimumab) AC Pen [Reference Product]
Adalimumab Richmond [Test Product]Active comparatorA single subcutaneous dose of 40 mg of the Test Product- Adalimumab Richmond [Test Product]
Receives: Biological: Adalimumab Richmond [Test Product]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Serum Concentration of adalimumab (Cmax)

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

    Measured: 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

  2. 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

    Measured: Day 1 to Day 71

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

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

    Measured: Day 1 to Day 71

Secondary outcomes (1)

  1. Number of samples with positive Anti-adalimumab serum antibodies

    Anti-adalimumab serum antibodies detection

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start1 Aug 2022
  3. Primary completion10 Jan 2023
  4. Study completion20 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Randomized, Double Blind, Parallel groups, Phase 1 Clinical Study comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06291948
Sponsor's protocol ID
0225
Status last verified
Feb 2024
First submitted
4 Dec 2023
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11590294

  • 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

  • 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.

    PubMed 27813422

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Humira® (adalimumab) AC Pen [Reference Product] and Adalimumab Richmond [Test Product] in people with Pharmacokinetics and Safety Issues, run by Laboratorios Richmond S.A.C.I.F. at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Serum Concentration of adalimumab (Cmax) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06291948, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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