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

Launched by UBP GREATER CHINA (SHANGHAI) CO., LTD · Jul 19, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a medication called UB-621 for adults who experience recurrent genital herpes caused by the HSV-2 virus. The main goal is to see if UB-621 can help reduce the number of herpes outbreaks and to understand how the body processes this medication. The trial is currently not recruiting participants, but when it starts, it will be looking for adults aged 18 and older who have had at least six herpes outbreaks in the past year and who test positive for the HSV-2 virus.

If you qualify for this study, you will be asked to keep a daily diary of your symptoms and to visit the study site within three days after any new herpes lesions appear. Females participating in the trial will need to confirm they are not pregnant and use contraception during the study. It’s important to note that certain medical conditions, like a history of cancer or autoimmune diseases, may prevent someone from joining the trial. Participants will receive close monitoring throughout the study to ensure their safety and the effectiveness of the treatment.

Gender

ALL

Eligibility criteria

• 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