drugset / Trial / NCT04428814
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy Male Subjects.
Timeline
- Start
- 2020-08-03
- Primary completion
- 2021-02-24
- Completion
- 2021-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CT-P43 | Protein / enzyme biologic | 45 mg | Subcutaneous |
| Comparator | Ustekinumab | Monoclonal antibody | 45 mg | Subcutaneous |
Indications
No indication recorded.