A Two-Stage, Randomized, Double-Blind, Dose-Ranging, Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 on HSV Shedding in Adults With Recurrent Genital HSV-2 Infection.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 主要终点
- change of HSV-2 shedding rate.
研究概览
简要总结
To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.
详细描述
This is a 2-stage, randomized, double-blind, dose-ranging, multi-center phase 2 study designed to evaluate the efficacy, safety, and PK of UB-621 given at 2.5 or 5 mg/kg in adult subjects with recurrent genital HSV-2 infection. The study consists of 2 stages of enrollments, in which 40 subjects will be enrolled in the first stage and randomly assigned to receive placebo or UB-621 at 2.5 mg/kg in a 1:3 ratio into Cohort 1 at Bv6 (Day B57), and another 40 subjects will be enrolled in the second stage and randomly assigned to receive placebo or UB-621 at 5 mg/kg in a 1:3 ratio into Cohort 2 at Bv6 (Day B57) after review by the Data Safety Monitoring Committee (DSMC). The DSMC will review safety data after all subjects of Cohort 1 complete the visit Fv6 (Day F28) and make the recommendation whether to proceed with enrollment for Cohort 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age inclusive.
- •Subject must be HSV-2 seropositive
- •Subjects have a history of recurrent genital herpes in the past year
- •Subjects have a negative result on the HIV Ab/Ag assay
- •Subjects must agree to use contraception during study participation
- •Subjects must be willing NOT to use any topical genital therapy and systemic anti-HSV therapy from the beginning of the study till the end of week
- •Subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks prior to and upon the administration of study drug.
- •Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.
排除标准
- •Serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except HSV) in the anogenital area, etc. that may interfere with the assessment of the efficacy of UB-
- •Documented HSV resistance to acyclovir, valacyclovir, famciclovir, or penciclovir
- •History or current evidence of malignancy except for a localized non-melanoma skin cancer
- •Known immunosuppression
- •Exposure to HSV vaccine
- •Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)
- •Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study
- •Treatment with systemic steroids or other immunomodulating agents within 30 days prior to Screening or planned treatment with systemic steroids or immunomodulators during the study period.
- •Renal impairment and/or hepatic impairment
- •ECG abnormalities of clinical relevance or cardiovascular conditions
结局指标
主要结局
change of HSV-2 shedding rate.
时间窗: 112 days
The primary endpoint for this study is to evaluate the reduction in HSV-2 shedding rate within subjects in the Baseline Period versus Follow-up Period.
次要结局
- Clinical and Subclinical HSV-2 Shedding Rates(196 days)
- Rate of HSV-2 Shedding Episodes(196)
- change of genital lesion rates(140 days)
- change of HSV-2 viral load(112 days)