Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
Launched by UNITED BIOPHARMA · Aug 13, 2018
Trial Information
Current as of June 13, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
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.
- • 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.
About United Biopharma
United Biopharma is a leading clinical trial sponsor dedicated to advancing innovative therapies in the biopharmaceutical sector. With a strong commitment to research and development, the organization focuses on addressing unmet medical needs through the discovery and commercialization of novel treatments. United Biopharma collaborates with healthcare professionals, regulatory authorities, and research institutions to ensure the highest standards of clinical trial design and execution. Their mission is to enhance patient outcomes by bringing safe and effective therapies to market, driven by a patient-centric approach and a commitment to scientific excellence.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Taipei, , Taiwan
Taipei, , Taiwan
Kaohsiung, , Taiwan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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