Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes

Study Overview
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Brief Summary
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To evaluate the efficacy of repeat-dose UB-621 for the recurrent genital HSV-2 infection To evaluate the safety and tolerance of repeat-dose UB-621 for the recurrent HSV-2 infection To evaluate the pharmacokinetics of repeat-dose UB-621 in RGH patients

Official Title
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A Randomized, Single-blind, Placebo-control, Parallel, Phase II Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection

Conditions
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Recurrent Genital Herpes

Intervention / Treatment
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* Other: Placebo
* Biological: UB-621 low-dose
* Biological: UB-621 high-dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≧18 years at the time of signing ICF HSV-2 seropositive when screening A history of recurrent genital herpes and experience 6-12 episodes in the past year Negative result of the HIV assay In baseline period, subject have to present at the site within 72 hours after the occurrence of new lesions Keep daily diary during the study period Female subjects: negative serum β-HCG at screening and no beast-feeding. Use contraception during study participation Understanding and willing to fully comply with study interventions and restrictions. Exclusion Criteria: Any medical conditions that may interfere the assessment of UB-621efficacy, or any medical conditions that may present symptoms in the anogenital regions (such as syphilis, genital warts). History of malignancy, diabetes, auto-immune diseases or immunodificiency diseases. Use of systemic steroids or immunomodulators within 30 days prior to the screening Participating any clinical trials within 30 days prior to the screening, or within 5 half-life of any investigational drugs, take the longer. Vaccination within 30 days prior to the screening. Prior exposure to any HSV vaccines Known hypersensitive to monoclonal antibodies ECG abnormalities with clinical relevance or cardiovascular diseases at screening Serum creatinine > 1.5 mg/dL at screening AST and ALT > 2.5 x ULN at screening HBsAg positive or HCT antibody positive at screening Syphilis RPR test positive at screening TB history or documented T-spot positive, or now is under treatment of TB Any other circumstances that are determined to affect the conduct or successful completion of the clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>placebo matching UB-621 | Other: Placebo<br>* PBO- placebo matching to UB-621<br>|
| Experimental: UB-621 low-dose<br>low-dose of UB-621 | Biological: UB-621 low-dose<br>* fully human anti-HSV mAb<br>|
| Experimental: UB-621 high-dose<br>high-dose of UB-621 | Biological: UB-621 high-dose<br>* fully human anti-HSV mAb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first recurrence | Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with episodes | Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. | 26 weeks | 
| Lesion rate | Lesion rate is calculated as the number of days with lesion divided by the number of study days. | 26 weeks | 
| Duration of recurrent lesions | Duration of recurrent lesions is calculated as consecutive days with lesions. | 26 weeks | 
| Recurrence rate | Recurrence rate is defined as number of recurrences divided by the total number of study days. | 26 weeks |