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.