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

United BioPharma

Status and phase: Completed; Phase 1

Conditions: Urticaria Chronic

Treatments: Biological: UB-221

Study type: Interventional

Funder types: Industry

Identifiers

NCT03632291

UBP-A107-IgE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

15 participants in 5 patient groups

UB-221 (0.2 mg/kg)

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-221

UB-221 (0.6 mg/kg)

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-221

UB-221 (2 mg/kg)

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-221

UB-221 (6 mg/kg)

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-221

UB-221 (10 mg/kg)

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-221