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

Launched by UNITED BIOPHARMA · Nov 21, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called UB-221 for people with chronic spontaneous urticaria, which is a condition that causes long-lasting hives and itching. The main goal is to see how safe UB-221 is and how well it works in the body after a single dose. The researchers will start with a low dose and gradually increase it to find the highest dose that people can tolerate without serious side effects.

To participate in this study, you need to be at least 18 years old and have been diagnosed with chronic spontaneous urticaria for more than six weeks. It's important to note that individuals with certain health issues, like autoimmune diseases or serious mental health conditions, may not be eligible to join. If you choose to participate, you will receive the medication and be monitored for any side effects, helping the researchers understand more about this potential new treatment.

Gender

ALL

Eligibility 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.