Recurrent Genital Herpes
Conditions
Brief summary
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
Interventions
OTHERPlacebo
PBO- placebo matching to UB-621
BIOLOGICALUB-621 low-dose
fully human anti-HSV mAb
BIOLOGICALUB-621 high-dose
fully human anti-HSV mAb
Sponsors
UBP Greater China (Shanghai) Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≧18 years at the time of signing ICF 2. HSV-2 seropositive when screening 3. A history of recurrent genital herpes and experience 6-12 episodes in the past year 4. Negative result of the HIV assay 5. In baseline period, subject have to present at the site within 72 hours after the occurrence of new lesions 6. Keep daily diary during the study period 7. Female subjects: negative serum β-HCG at screening and no beast-feeding. 8. Use contraception during study participation 9. Understanding and willing to fully comply with study interventions and restrictions.
Exclusion criteria
1. 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). 2. History of malignancy, diabetes, auto-immune diseases or immunodificiency diseases. 3. Use of systemic steroids or immunomodulators within 30 days prior to the screening 4. Participating any clinical trials within 30 days prior to the screening, or within 5 half-life of any investigational drugs, take the longer. 5. Vaccination within 30 days prior to the screening. 6. Prior exposure to any HSV vaccines 7. Known hypersensitive to monoclonal antibodies 8. ECG abnormalities with clinical relevance or cardiovascular diseases at screening 9. Serum creatinine \> 1.5 mg/dL at screening 10. AST and ALT \> 2.5 x ULN at screening 11. HBsAg positive or HCT antibody positive at screening 12. Syphilis RPR test positive at screening 13. TB history or documented T-spot positive, or now is under treatment of TB 14. Any other circumstances that are determined to affect the conduct or successful completion of the clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first recurrence | 26 weeks | Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with episodes | 26 weeks | Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. |
| Lesion rate | 26 weeks | Lesion rate is calculated as the number of days with lesion divided by the number of study days. |
| Duration of recurrent lesions | 26 weeks | Duration of recurrent lesions is calculated as consecutive days with lesions. |
| Recurrence rate | 26 weeks | Recurrence rate is defined as number of recurrences divided by the total number of study days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Subclinical HSV-2 Shedding Rates | 12 weeks | Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the follow-up periods will be used to evaluate the clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates. |
| Rate of HSV-2 Shedding Episodes | 12 weeks | The rate of HSV-2 shedding episodes is the number of onsets of shedding episodes divided by the total number of days with swabs collected. Shedding episodes are defined as consecutive HSV-2 positive swab results including no more than 1 consecutive negative result or missed swab. The episodes are preceded and followed by 2 consecutive negative swab results. |
| HSV-2 viral load | 12 weeks | Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies. |
| HSV-2 shedding rate | 12 weeks | Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs. |
Contacts
Primary ContactLinda Shih, DVM
Outcome results
None listed