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

Herpes Simplex Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346760
• Other study ID #: A101-HSV
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: January 2017

Study information

• Verified date: April 2019
• Source: United BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex Virus Infection
• Virus Diseases

Intervention

Drug:
• UB-621
100 mg/ml, subcutaneous injection

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
United BioPharma	Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Up to 70 or 112 days
Secondary	Peak concentration of UB-621		Up to 70 or 112 days