A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers

UBP Greater China (Shanghai) Co., Ltd0 sites15 target enrollmentDecember 1, 2023

ConditionsChronic Spontaneous Urticaria

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Spontaneous Urticaria
Sponsor: UBP Greater China (Shanghai) Co., Ltd
Enrollment: 15
Primary Endpoint: 1.Adverse event incidence
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Detailed Description

This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

December 1, 2023

End Date

June 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

UBP Greater China (Shanghai) Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with age between 20 to 65 years old (inclusive).
•Subjects who are able and willing to provide the informed consent.
•Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above.
•Researchers based on medical history, physical examination, vital signs, clinical laboratory results and 12-lead electrocardiogram identified healthy subjects without clinically significant abnormalities