drugset / Trial / NCT04404023

Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers

NCT04404023 ↗

Phase 1 Unknown 15 enrolled UBP Greater China (Shanghai) Co., Ltd
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

Timeline

Start
2023-12-01
Primary completion
2024-06
Completion
2025-06

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