Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers

United BioPharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Chronic Spontaneous Urticaria

Treatments: Biological: UB-221

Study type: Interventional

Funder types: Industry

Identifiers

NCT04404023

UBP-A124-IgE

Details and patient eligibility

About

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

Full description

This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.

Enrollment: 15 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts 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.
• Researchers based on medical history, physical examination, vital signs, clinical laboratory results and 12-lead electrocardiogram identified healthy subjects without clinically significant abnormalities

Exclusion criteria

• The investigator considered that the subjects were 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