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

Phase 2

Not yet recruiting

• Conditions: Recurrent Genital Herpes
• Interventions: Other: Placebo; Biological: UB-621 high-dose; Biological: UB-621 low-dose

• Registration Number: NCT04979975
• Lead Sponsor: UBP Greater China (Shanghai) Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03
• Study Start: 2023-12
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo matching UB-621
UB-621 high-dose	UB-621 high-dose	high-dose of UB-621
UB-621 low-dose	UB-621 low-dose	low-dose of UB-621

Primary Outcome Measures

Name	Time	Method
Time to first recurrence	26 weeks	Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.

Secondary Outcome Measures

Name	Time	Method
Duration of recurrent lesions	26 weeks	Duration of recurrent lesions is calculated as consecutive days with lesions.
Lesion rate	26 weeks	Lesion rate is calculated as the number of days with lesion divided by the number of study days.
Recurrence rate	26 weeks	Recurrence rate is defined as number of recurrences divided by the total number of study days.
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.