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

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

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Herpes Simplex Virus Infection
• Intervention / Treatment: Drug: UB-621

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UB-621; Intervention drug: UB-621	Drug: UB-621; 100 mg/ml, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Up to 70 or 112 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak concentration of UB-621	Up to 70 or 112 days

Collaborators and Investigators

• Sponsor: United BioPharma
• Collaborators: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Wing Wai Wong, MD, Taipei Veterans General Hoapital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex
• Other Study ID Numbers: A101-HSV