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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Herpes Simplex Virus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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UB-621

Intervention drug: UB-621

Group Type EXPERIMENTAL

UB-621

Intervention Type DRUG

100 mg/ml, subcutaneous injection

Interventions

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UB-621

100 mg/ml, subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes