Overview

Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria

Status:
Not yet recruiting

Trial end date:
2024-01-30

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

United BioPharma

Treatments:

Antibodies
Antibodies, Monoclonal