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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
UBP Greater China (Shanghai) Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 21, 2020
    Last Updated
    May 16, 2022
    Sponsor
    UBP Greater China (Shanghai) Co., Ltd
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    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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