Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
150 participants
INTERVENTIONAL
2022-08-01
2023-10-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
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).
Study Groups
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Humira® (adalimumab) AC Pen [Reference Product]
A single subcutaneous dose of 40 mg of the Reference Product- Humira® AC Pen \[Reference Product\]
Humira® (adalimumab) AC Pen [Reference Product]
A single subcutaneous dose
Adalimumab Richmond [Test Product]
A single subcutaneous dose of 40 mg of the Test Product- Adalimumab Richmond \[Test Product\]
Adalimumab Richmond [Test Product]
A single subcutaneous dose
Interventions
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Humira® (adalimumab) AC Pen [Reference Product]
A single subcutaneous dose
Adalimumab Richmond [Test Product]
A single subcutaneous dose
Eligibility Criteria
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Inclusion Criteria
* Study subjects must be able to understand and comply with the protocol.
* Study subjects must be willing and able to provide written informed consent.
2. 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.
3. 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.
Exclusion Criteria
* 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.
2. 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.
3. 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 \[and for a period of not less than 5 months after the last dose of the investigational product\].
4. Allergies, adverse drug reactions and contraindications
\- Study subjects with allergies, adverse drug reactions or contraindications to therapy.
5. Prohibited treatments and/or therapies
\- The study subjects must have suspended any drug treatments at least 2 weeks before starting this clinical research protocol.
* 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.
21 Years
55 Years
ALL
Yes
Sponsors
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FP Clinical Pharma S.R.L.
INDUSTRY
Custom Biologics
UNKNOWN
Laboratorios Richmond S.A.C.I.F.
INDUSTRY
Responsible Party
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Principal Investigators
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Ethel C. Feleder, MD
Role: PRINCIPAL_INVESTIGATOR
FP Clinical Pharma S.R.L.
Locations
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FP Clinical Pharma S.R.L.
Buenos Aires, , Argentina
Countries
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References
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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.
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.
Related Links
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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
Other Identifiers
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0225
Identifier Type: -
Identifier Source: org_study_id
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