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

Phase 1

Not yet recruiting

• Conditions: Chronic Spontaneous Urticaria
• Interventions: Biological: UB-221

• Registration Number: NCT04404023
• Lead Sponsor: UBP Greater China (Shanghai) Co., Ltd

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.

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18
• Study Start: 2023-12-01
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Exclusion Criteria

• The investigator considered that the subjects were not suitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
UB-221 (2 mg/kg)	UB-221	Intravenous infusion
UB-221 (6 mg/kg)	UB-221	Intravenous infusion
UB-221 (0.6 mg/kg)	UB-221	Intravenous infusion
UB-221 (0.2 mg/kg)	UB-221	Intravenous infusion
UB-221 (10 mg/kg)	UB-221	Intravenous infusion

Primary Outcome Measures

Name	Time	Method
1.Adverse event incidence	15 days	from the baseline to day 15 after IP infusion