protocolSection identificationModule nctId: NCT06291948, orgStudyIdInfo id: 0225, briefTitle: A Clinical Study With Adalimumab Biosimilar, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2023-01-10, completionDateStruct date: 2023-10-20, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Laboratorios Richmond S.A.C.I.F., class: INDUSTRY, collaborators name: FP Clinical Pharma S.R.L., collaborators name: Custom Biologics, descriptionModule briefSummary: 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 \[Reference Product\], conditionsModule conditions: Pharmacokinetics, conditions: Safety Issues, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized, Double Blind, Parallel groups, Phase 1 Clinical Study comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects., primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: 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)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: Humira® (adalimumab) AC Pen [Reference Product], interventions name: Adalimumab Richmond [Test Product], outcomesModule primaryOutcomes measure: Peak Serum Concentration of adalimumab (Cmax), primaryOutcomes measure: Area Under the Serum Concentration-time Curve of adalimumab (ABC0-t), primaryOutcomes measure: Area Under the Serum Concentration- Time Curve ob adalimumab (ABC0-∞), secondaryOutcomes measure: Number of samples with positive Anti-adalimumab serum antibodies, otherOutcomes measure: Adverse Events, otherOutcomes measure: Number of positive Anti-adalimumab serum samples with neutralizing capacity, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: FP Clinical Pharma S.R.L., city: Buenos Aires, zip: C1425BAA, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, hasResults: False