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Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects

NCT04439929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2020-06-19

No results posted yet for this study

Summary

This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.

Conditions

  • Healthy Participants

Interventions

BIOLOGICAL

TUR01

Administered as a single 40 mg, subcutaneous dose

BIOLOGICAL

Adalimumab-EU

Administered as a single 40 mg, subcutaneous dose

Sponsors & Collaborators

  • Turgut İlaçları A.Ş.

    lead INDUSTRY

Principal Investigators

  • Rainard Fuhr · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2020-01-16
Completion
2020-01-16

Countries

  • Germany

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 NCT04439929 on ClinicalTrials.gov