Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
Primary Purpose
Chronic Spontaneous Urticaria
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
UB-221
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria
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
Exclusion Criteria:
• The investigator considered that the subjects were not suitable to participate in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
UB-221 (0.2 mg/kg)
UB-221 (0.6 mg/kg)
UB-221 (2 mg/kg)
UB-221 (6 mg/kg)
UB-221 (10 mg/kg)
Arm Description
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Outcomes
Primary Outcome Measures
1.Adverse event incidence
from the baseline to day 15 after IP infusion
Secondary Outcome Measures
Full Information
NCT ID
NCT04404023
First Posted
May 21, 2020
Last Updated
May 16, 2022
Sponsor
UBP Greater China (Shanghai) Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04404023
Brief Title
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UBP Greater China (Shanghai) Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UB-221 (0.2 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (0.6 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (2 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (6 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (10 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Intervention Type
Biological
Intervention Name(s)
UB-221
Intervention Description
UB-221 (75 mg/ml)
Primary Outcome Measure Information:
Title
1.Adverse event incidence
Description
from the baseline to day 15 after IP infusion
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Exclusion Criteria:
• The investigator considered that the subjects were not suitable to participate in this study.
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
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