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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
PBO- placebo matching to UB-621
fully human anti-HSV mAb
fully human anti-HSV mAb
Time to first recurrence
Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
Time frame: 26 weeks
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.
Time frame: 26 weeks
Lesion rate
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Time frame: 26 weeks
Duration of recurrent lesions
Duration of recurrent lesions is calculated as consecutive days with lesions.
Time frame: 26 weeks
Recurrence rate
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Time frame: 26 weeks
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