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

Sponsor
United BioPharma (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04175704
Collaborator
(none)
32
Enrollment
4
Arms
25
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 30, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Cohort 1

0.2 mg/kg UB-221 or placebo

Drug: UB-221
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
Other Names:
  • recombinant anti-IgE humanized IgG1 monoclonal antibody

    		•
    Other: Cohort2

    0.6 mg/kg UB-221 or placebo

    Drug: UB-221
    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
    Other Names:
  • recombinant anti-IgE humanized IgG1 monoclonal antibody

    		•
    Other: Cohort 3

    2 mg/kg UB-221 or placebo

    Drug: UB-221
    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
    Other Names:
  • recombinant anti-IgE humanized IgG1 monoclonal antibody

    		•
    Other: Cohort 4

    6 mg/kg UB-221 or placebo

    Drug: UB-221
    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
    Other Names:
  • recombinant anti-IgE humanized IgG1 monoclonal antibody

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients [99 days]

      1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • United BioPharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    United BioPharma
    ClinicalTrials.gov Identifier:
    NCT04175704
    Other Study ID Numbers:
    • UBP-A115-IgE
    First Posted:
    Nov 25, 2019
    Last Update Posted:
    Dec 14, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urticaria
    Chronic Urticaria

    Study Results

    No Results Posted as of Dec 14, 2020