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

United BioPharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Chronic Idiopathic Urticaria

Treatments: Drug: UB-221

Study type: Interventional

Funder types: Industry

Identifiers

NCT04175704

UBP-A115-IgE

Details and patient eligibility

About

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.

Full description

This is a phase I, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of UB-221 as an add-on therapy in chronic spontaneous urticaria (CSU) subjects who fail to respond to the first line H1-antihistamine treatment. Only the qualified subjects will be blinded to receive treatment. Each subject will receive only one dose of UB-221 or placebo.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups

Cohort 1

Other group

Description:

0.2 mg/kg UB-221 or placebo

Treatment:

Drug: UB-221

Cohort2

Other group

Description:

0.6 mg/kg UB-221 or placebo

Treatment:

Drug: UB-221

Cohort 3

Other group

Description:

2 mg/kg UB-221 or placebo

Treatment:

Drug: UB-221

Cohort 4

Other group

Description:

6 mg/kg UB-221 or placebo

Treatment:

Drug: UB-221