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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02346760

Enrollment

Registered

2015-01-27

Start date

2015-12-31

Completion date

2017-01-31

Last updated

2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex Virus Infection

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.

Interventions

DRUGUB-621

100 mg/ml, subcutaneous injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	Up to 70 or 112 days

Secondary

Measure	Time frame
Peak concentration of UB-621	Up to 70 or 112 days

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026