Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
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
1 other identifier
interventional
15
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMay 18, 2022
May 1, 2022
6 months
May 21, 2020
May 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
1.Adverse event incidence
from the baseline to day 15 after IP infusion
15 days
Study Arms (5)
UB-221 (0.2 mg/kg)
EXPERIMENTALIntravenous infusion
UB-221 (0.6 mg/kg)
EXPERIMENTALIntravenous infusion
UB-221 (2 mg/kg)
EXPERIMENTALIntravenous infusion
UB-221 (6 mg/kg)
EXPERIMENTALIntravenous infusion
UB-221 (10 mg/kg)
EXPERIMENTALIntravenous infusion
Interventions
UB-221 (75 mg/ml)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- The investigator considered that the subjects were not suitable to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2020
First Posted
May 27, 2020
Study Start
December 1, 2023
Primary Completion
June 1, 2024
Study Completion
June 1, 2025
Last Updated
May 18, 2022
Record last verified: 2022-05