NCT02346760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

January 14, 2015

Last Update Submit

April 16, 2019

Conditions

Herpes Simplex Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Up to 70 or 112 days

Secondary Outcomes (1)

  • Peak concentration of UB-621

    Up to 70 or 112 days

Study Arms (1)

UB-621

EXPERIMENTAL

Intervention drug: UB-621

Drug: UB-621

Interventions

UB-621DRUG

100 mg/ml, subcutaneous injection

UB-621

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wing Wai Wong, MD

    Taipei Veterans General Hoapital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 27, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

TW(1)