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Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria

Primary Purpose

Chronic Idiopathic Urticaria

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
UB-221
Sponsored by
United BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Urticaria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects aged ≥ 18 years
  • Subjects who are able and willing to provide the informed consent
  • Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history.

Exclusion Criteria:

  • History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Cohort 1

    Cohort2

    Cohort 3

    Cohort 4

    Arm Description

    0.2 mg/kg UB-221 or placebo

    0.6 mg/kg UB-221 or placebo

    2 mg/kg UB-221 or placebo

    6 mg/kg UB-221 or placebo

    Outcomes

    Primary Outcome Measures

    To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
    1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2019
    Last Updated
    September 29, 2022
    Sponsor
    United BioPharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04175704
    Brief Title
    Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
    Official Title
    A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2024 (Anticipated)
    Study Completion Date
    January 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    United BioPharma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.
    Detailed Description
    This is a phase I, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of UB-221 as an add-on therapy in chronic spontaneous urticaria (CSU) subjects who fail to respond to the first line H1-antihistamine treatment. Only the qualified subjects will be blinded to receive treatment. Each subject will receive only one dose of UB-221 or placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Idiopathic Urticaria

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1
    Arm Type
    Other
    Arm Description
    0.2 mg/kg UB-221 or placebo
    Arm Title
    Cohort2
    Arm Type
    Other
    Arm Description
    0.6 mg/kg UB-221 or placebo
    Arm Title
    Cohort 3
    Arm Type
    Other
    Arm Description
    2 mg/kg UB-221 or placebo
    Arm Title
    Cohort 4
    Arm Type
    Other
    Arm Description
    6 mg/kg UB-221 or placebo
    Intervention Type
    Drug
    Intervention Name(s)
    UB-221
    Other Intervention Name(s)
    recombinant anti-IgE humanized IgG1 monoclonal antibody
    Intervention Description
    Name: UB-221 Active ingredient: Anti-IgE monoclonal antibody Dosage form: UB-221 drug product is presented as a sterile liquid for intravenous (IV) infusion. Each vial contains 75 mg/mL UB-221 in 1.12 mL of buffered solution
    Primary Outcome Measure Information:
    Title
    To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
    Description
    1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS
    Time Frame
    99 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects aged ≥ 18 years Subjects who are able and willing to provide the informed consent Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history. Exclusion Criteria: History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mico Hsu, Master
    Phone
    +886-3-668-4800
    Ext
    3201
    Email
    mico.hsu@unitedbiopharma.com

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria

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