drugset / Trial / NCT04439929
Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
Indications
No indication recorded.