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NCT04404023 Clinical Trial

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

Chronic Spontaneous Urticaria Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04404023
Other study ID # UBP-A124-IgE
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2023
Est. completion date June 2025

Study information
Verified date May 2022
Source UBP Greater China (Shanghai) Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• UB-221
UB-221 (75 mg/ml)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UBP Greater China (Shanghai) Co., Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary 1.Adverse event incidence from the baseline to day 15 after IP infusion 15 days
See also
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