Status:
UNKNOWN
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
Lead Sponsor:
UBP Greater China (Shanghai) Co., Ltd
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- • The investigator considered that the subjects were not suitable to participate in this study.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04404023
Start Date
December 1 2023
End Date
June 1 2025
Last Update
May 18 2022
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