Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
NCT ID: NCT04979975
Last Updated: 2022-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2023-12-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo
placebo matching UB-621
Placebo
PBO- placebo matching to UB-621
UB-621 low-dose
low-dose of UB-621
UB-621 low-dose
fully human anti-HSV mAb
UB-621 high-dose
high-dose of UB-621
UB-621 high-dose
fully human anti-HSV mAb
Interventions
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Placebo
PBO- placebo matching to UB-621
UB-621 low-dose
fully human anti-HSV mAb
UB-621 high-dose
fully human anti-HSV mAb
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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UBP Greater China (Shanghai) Co., Ltd
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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UBP-A229-HSV
Identifier Type: -
Identifier Source: org_study_id
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