Not Yet RecruitingPhase 2

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

200 participantsStarted 2023-12

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

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

What they're measuring

Time to first recurrence

Timeframe: 26 weeks

Trial details

NCT IDNCT04979975

SponsorUBP Greater China (Shanghai) Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Linda Shih, DVM

+886 36684800 linda.shih@unitedbiopharma.com

View on ClinicalTrials.gov More Recurrent Genital Herpes trials