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A Clinical Study With Adalimumab Biosimilar

NCT06291948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-04

No results posted yet for this study

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 \[Reference Product\]

Conditions

  • Pharmacokinetics
  • Safety Issues

Interventions

BIOLOGICAL

Humira® (adalimumab) AC Pen [Reference Product]

A single subcutaneous dose

BIOLOGICAL

Adalimumab Richmond [Test Product]

A single subcutaneous dose

Sponsors & Collaborators

  • FP Clinical Pharma S.R.L.

    collaborator INDUSTRY

  • Custom Biologics

    collaborator UNKNOWN

  • Laboratorios Richmond S.A.C.I.F.

    lead INDUSTRY

Principal Investigators

  • Ethel C. Feleder, MD · FP Clinical Pharma S.R.L.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-01-10
Completion
2023-10-20

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06291948 on ClinicalTrials.gov