Overview

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

Status:
Not yet recruiting
Trial end date:
2024-01-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
United BioPharma
Treatments:
Antibodies
Antibodies, Monoclonal
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.