drugset / Trial / NCT03632291

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients

NCT03632291 ↗

Phase 1 Completed 15 enrolled United BioPharma
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Timeline

Start
2019-04-09
Primary completion
2021-01-19
Completion
2021-01-19

Drugs

EvaluationDrugModalityDoseRoute
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
Subject UB-221 Monoclonal antibody 10 mg/kg Intravenous

Indications