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

United BioPharma

Status and phase

Completed

Phase 1

Conditions

Herpes Simplex Virus Infection

Treatments

Drug: UB-621

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02346760

A101-HSV

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.