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

Phase 1

Completed

• Conditions: Herpes Simplex Virus Infection
• Interventions: Drug: UB-621

• Registration Number: NCT02346760
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Study Start: 2015-12
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UB-621	UB-621	Intervention drug: UB-621

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 70 or 112 days

Secondary Outcome Measures

Name	Time	Method
Peak concentration of UB-621	Up to 70 or 112 days

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan