A Clinical Study With Adalimumab Biosimilar

Sponsor
Laboratorios Richmond S.A.C.I.F.
Study ID
NCT06291948
Phase
PHASE1
Status
Completed

Conditions

  • Pharmacokinetics
  • Safety Issues

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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 \[Reference Product\]

Key Dates

Start date
Aug 1, 2022
Status verified
Feb 2024
Primary completion
Jan 10, 2023
Completion
Oct 20, 2023

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Humira® (adalimumab) AC Pen [Reference Product]
    A single subcutaneous dose of 40 mg of the Reference Product- Humira® AC Pen \[Reference Product\]
  • Active Comparator: Adalimumab Richmond [Test Product]
    A single subcutaneous dose of 40 mg of the Test Product- Adalimumab Richmond \[Test Product\]

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 ]

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