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

May 16, 2022 updated by: UBP Greater China (Shanghai) Co., Ltd

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UB-221 (0.2 mg/kg)
Intravenous infusion
Biological: UB-221
UB-221 (75 mg/ml)
Experimental: UB-221 (0.6 mg/kg)
Intravenous infusion
Biological: UB-221
UB-221 (75 mg/ml)
Experimental: UB-221 (2 mg/kg)
Intravenous infusion
Biological: UB-221
UB-221 (75 mg/ml)
Experimental: UB-221 (6 mg/kg)
Intravenous infusion
Biological: UB-221
UB-221 (75 mg/ml)
Experimental: UB-221 (10 mg/kg)
Intravenous infusion
Biological: UB-221
UB-221 (75 mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1.Adverse event incidence
Time Frame: 15 days
from the baseline to day 15 after IP infusion
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UBP Greater China (Shanghai) Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBP-A124-IgE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Spontaneous Urticaria

Clinical Trials on UB-221

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe