Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
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
1 other identifier
interventional
32
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2023
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 25, 2019
CompletedStudy Start
First participant enrolled
December 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedOctober 3, 2022
September 1, 2022
11 months
November 12, 2019
September 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
99 days
Study Arms (4)
Cohort 1
OTHER0.2 mg/kg UB-221 or placebo
Cohort2
OTHER0.6 mg/kg UB-221 or placebo
Cohort 3
OTHER2 mg/kg UB-221 or placebo
Cohort 4
OTHER6 mg/kg UB-221 or placebo
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United BioPharmalead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2019
First Posted
November 25, 2019
Study Start
December 30, 2023
Primary Completion
November 30, 2024
Study Completion
January 30, 2026
Last Updated
October 3, 2022
Record last verified: 2022-09