drugset / Trial / NCT04175704
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.
Timeline
- Start
- 2023-12-30
- Primary completion
- 2024-11-30
- Completion
- 2026-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UB-221 | Monoclonal antibody | 0.2 mg/kg | Intravenous |
| Subject | UB-221 | Monoclonal antibody | 0.6 mg/kg | Intravenous |
| Subject | UB-221 | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | UB-221 | Monoclonal antibody | 6 mg/kg | Intravenous |