Trials / Completed
CompletedNCT06291948
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Laboratorios Richmond S.A.C.I.F. · Industry
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Humira® (adalimumab) AC Pen [Reference Product] | A single subcutaneous dose |
| BIOLOGICAL | Adalimumab Richmond [Test Product] | A single subcutaneous dose |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2023-01-10
- Completion
- 2023-10-20
- First posted
- 2024-03-04
- Last updated
- 2024-03-04
Locations
1 site across 1 country: Argentina
Source: ClinicalTrials.gov record NCT06291948. Inclusion in this directory is not an endorsement.