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

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