A randomized, single-blind, dose-selected phase II trial to evaluate the safety, efficacy and PK of UB-621 in adults with recurrent genital HSV-2 infection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
mAb by SC administration
Proportion of subjects with episodes before and after UB-621 treatment (self-comparison)
Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. Primary endpoint is the self-comparison of proportion of subjects with episodes before and after UB-621 treatment.
Time frame: 16 weeks
Lesion rate
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Time frame: 16 weeks
Duration of recurrent lesions
Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7.
Time frame: 16 weeks
Recurrence rate
Recurrence rate is defined as number of recurrences divided by the total number of study days.
Time frame: 16 weeks
Time to first recurrence of lesion
Time to first recurrence of lesion as reported by patient and verified by investigator.
Time frame: 16 weeks
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