CompletedPhase 1

A Clinical Study With Adalimumab Biosimilar

Argentina150 participantsStarted 2022-08-01

Plain-language 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 \[Reference Product\]

Who can participate

Age range21 Years – 55 Years

SexALL

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Inclusion criteria

✓. Written and signed informed consent
✓. Target population
✓. Age and gender

Exclusion criteria

✕. Medical history and concurrent illnesses
✕. Physical findings and laboratory tests
✕. Sex and reproductive condition
✕. Allergies, adverse drug reactions and contraindications
✕. Prohibited treatments and/or therapies
✕. Other exclusion criteria

What they're measuring

Peak Serum Concentration of adalimumab (Cmax)

Timeframe: 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

Area Under the Serum Concentration-time Curve of adalimumab (ABC0-t)

Timeframe: Day 1 to Day 71

Area Under the Serum Concentration- Time Curve ob adalimumab (ABC0-∞)

Timeframe: Day 1 to Day 71

Trial details

NCT IDNCT06291948

SponsorLaboratorios Richmond S.A.C.I.F.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-10

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