A Randomized, Double-blind, Parallel Groups, Phase 1 Clinical Study Comparing the Pharmacokinetic, Safety and Immunogenicity of Adalimumab in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pharmacokinetics
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Peak Serum Concentration of adalimumab (Cmax)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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]
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Cmax will be obtained directly from the serum concentration-time curve
Area Under the Serum Concentration-time Curve of adalimumab (ABC0-t)
Time Frame: Day 1 to Day 71
Area under the serum concentration-time curve from time zero to the last experimental point, will be calculated by the trapezoidal rule
Area Under the Serum Concentration- Time Curve ob adalimumab (ABC0-∞)
Time Frame: Day 1 to Day 71
Area under the serum concentration- time curve from time zero to infinity
Secondary Outcomes
- Number of samples with positive Anti-adalimumab serum antibodies(Screening, post dose: 672.0 hours, 1680.0 hours, 12 months)