NCT04979975尚未招募2 期
A Randomized, Single-blind, Placebo-control, Parallel, Phase II Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection
UBP Greater China (Shanghai) Co., Ltd0 个研究点目标入组 200 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Time to first recurrence
研究概览
简要总结
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
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
- Single (Participant)
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
- •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
- •Understanding and willing to fully comply with study interventions and restrictions.
排除标准
- •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
- •Serum creatinine > 1.5 mg/dL at screening
- •AST and ALT > 2.5 x ULN at screening
- •HBsAg positive or HCT antibody positive at screening
- •Syphilis RPR test positive at screening
- •TB history or documented T-spot positive, or now is under treatment of TB
- •Any other circumstances that are determined to affect the conduct or successful completion of the clinical study
结局指标
主要结局
Time to first recurrence
时间窗: 26 weeks
Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator.
次要结局
- Duration of recurrent lesions(26 weeks)
- Lesion rate(26 weeks)
- Recurrence rate(26 weeks)
- Proportion of subjects with episodes(26 weeks)
研究者
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