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Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02346760
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
United BioPharma

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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Virus Infection Drug: UB-621 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: UB-621
Intervention drug: UB-621
Drug: UB-621
100 mg/ml, subcutaneous injection




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to 70 or 112 days ]

Secondary Outcome Measures :
  1. Peak concentration of UB-621 [ Time Frame: Up to 70 or 112 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346760


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
United BioPharma
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Wing Wai Wong, MD Taipei Veterans General Hoapital
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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT02346760    
Other Study ID Numbers: A101-HSV
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Herpes Simplex
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases