drugset / Trial / NCT06481215
A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
RandomizedParallel-groupOpen-labelOther
Summary
This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg. The follow up period was 84 days.
Timeline
- Start
- 2022-03-11
- Primary completion
- 2022-09-04
- Completion
- 2022-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GNR-068 | Unknown | 45 mg | Subcutaneous |
| Comparator | Ustekinumab | Monoclonal antibody | 45 mg | Subcutaneous |
Indications
No indication recorded.