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Completed

NCT Number: NCT03632291

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

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Key information

Conditions

Urticaria Chronic Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

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About this study

This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Subjects diagnosed with chronic spontaneous urticaria (CSU).

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 is not suitable to participate in this study.

Treatment and study plan

UB-221

Biological

UB-221 (75 mg/ml)

Primary outcomes

  1. Adverse event incidence

    Time frame: 15 days

    from the baseline to day 15 after IP infusion

Sponsors and collaborators

Lead sponsor

United BioPharma

Industry

Registry information

Official study title

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2018
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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