A Clinical Study With Adalimumab Biosimilar

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]

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.

Inclusion Criteria:

1. 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.

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:

1. 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.

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.

6. 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.