Trials / Completed
CompletedNCT03632291
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- United BioPharma · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UB-221 | UB-221 (75 mg/ml) |
Timeline
- Start date
- 2019-04-09
- Primary completion
- 2021-01-19
- Completion
- 2021-01-19
- First posted
- 2018-08-15
- Last updated
- 2022-05-13
Locations
2 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03632291. Inclusion in this directory is not an endorsement.