A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria
Overview
- Phase
- Phase 1
- Intervention
- UB-221
- Conditions
- Chronic Idiopathic Urticaria
- Sponsor
- United BioPharma
- Enrollment
- 32
- Primary Endpoint
- To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
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.
Arms & Interventions
Cohort 1
0.2 mg/kg UB-221 or placebo
Intervention: UB-221
Cohort2
0.6 mg/kg UB-221 or placebo
Intervention: UB-221
Cohort 3
2 mg/kg UB-221 or placebo
Intervention: UB-221
Cohort 4
6 mg/kg UB-221 or placebo
Intervention: UB-221
Outcomes
Primary Outcomes
To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
Time Frame: 99 days
1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS