Back to resultsStudy to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers
Primary Purpose
Herpes Simplex Virus Infection
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
UB-621
Sponsored by
About this trial
This is an interventional other trial for Herpes Simplex Virus Infection
Eligibility Criteria
Inclusion Criteria:
- With age between 20 and 55 years.
- With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.
- Body weight: <85 kg.
- Subject has signed the written informed consent form.
Exclusion Criteria:
- With significant active infection (acute or chronic) within 28 days prior to the screening visit.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.
- Positive serology for HIV antibody, HCV antibody or HBV surface antigen.
- Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.
- The clinical investigator considers that the subject is not in the condition to participate in this study.
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UB-621
Arm Description
Intervention drug: UB-621
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Secondary Outcome Measures
Peak concentration of UB-621
Full Information
NCT ID
NCT02346760
First Posted
January 14, 2015
Last Updated
April 16, 2019
Sponsor
United BioPharma
Collaborators
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02346760
Brief Title
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers
Official Title
A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Dose of UB-621 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United BioPharma
Collaborators
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.
Detailed Description
This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Virus Infection
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UB-621
Arm Type
Experimental
Arm Description
Intervention drug: UB-621
Intervention Type
Drug
Intervention Name(s)
UB-621
Intervention Description
100 mg/ml, subcutaneous injection
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Up to 70 or 112 days
Secondary Outcome Measure Information:
Title
Peak concentration of UB-621
Time Frame
Up to 70 or 112 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
With age between 20 and 55 years.
With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.
Body weight: <85 kg.
Subject has signed the written informed consent form.
Exclusion Criteria:
With significant active infection (acute or chronic) within 28 days prior to the screening visit.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.
Positive serology for HIV antibody, HCV antibody or HBV surface antigen.
Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.
The clinical investigator considers that the subject is not in the condition to participate in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Wai Wong, MD
Organizational Affiliation
Taipei Veterans General Hoapital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers
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