drugset / Trial / NCT04439929

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

NCT04439929

Phase 1 Completed 168 enrolled Turgut İlaçları A.Ş.
RandomizedParallel-groupDouble-blindBasic science

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous

Indications

No indication recorded.