A Phase 1b, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Norovirus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of norovirus-confirmed disease
研究概览
简要总结
Participants in this study will be given either CDI-988 or placebo orally before receiving a norovirus challenge virus and continuing for 5 days. Participants will not know whether they are getting placebo or CDI-988. The study will evaluate how well CDI-988 compared to placebo can reduce the incidence of clinical symptoms after a challenge with norovirus. The amount of virus in stool samples will be measured over time. Side effects and pharmacokinetics (the amount of CDI-988 in blood) will also be measured.
详细描述
This is a single center Phase 1b randomized, double-blind, placebo-controlled study. The primary objective will be to evaluate the efficacy of CDI-988 in comparison to placebo in reducing the incidence of clinical symptoms after challenge with norovirus. Secondary objectives will be to evaluate the efficacy of CDI-988 in comparison to placebo in reducing viral shedding and disease severity and to evaluate the safety of CDI-988 in comparison to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non-pregnant female
- •Aged 18 to 49 years
- •Good state of health
- •Known fucosyl transferase 2 (FUT2) secretor status
排除标准
- •History of participation in any norovirus challenge or vaccine clinical trial
- •Receipt or planned receipt of any non-live vaccines within 7 days or live vaccines within 30 days before screening or prior to Day 28
- •History of suspected norovirus gastroenteritis or chronic/recurrent gastrointestinal symptoms (e.g., diarrhea or vomiting) within 2 years prior to screening
- •History of diagnosed gastrointestinal malabsorption disorders, major gastrointestinal surgery, or diagnosed chronic GI conditions
- •Presence of moderate or severe illness, fever (≥38°C), or diarrhea/vomiting within 7 days prior to challenge
- •Any acute illness on Day 1 (dosing day)
- •Positive Day 0 stool tests for enteric pathogens
- •Body weight <45 kg or BMI <18 or >32 kg/m² on Day 0
- •Use of immunosuppressive therapy within 6 months prior to Day 0 or having any primary or secondary immunocompromising condition
- •Use of high-dose systemic corticosteroids (≥20 mg/day prednisolone for ≥2 weeks) or high-dose inhaled steroids for >7 days within 6 months
研究组 & 干预措施
Stage 2: Drug CDI-988
干预措施: CDI-988 (Drug)
Stage 2: Drug CDI-988
干预措施: Snow Mountain Virus (Other)
Stage 2: Placebo
干预措施: Placebo (Drug)
Stage 2: Placebo
干预措施: Snow Mountain Virus (Other)
Snow Mountain Virus
Challenge with Snow Mountain Virus
干预措施: Snow Mountain Virus (Other)
结局指标
主要结局
Incidence of norovirus-confirmed disease
时间窗: Day 0 to Day 21
Disease is defined as diarrhea and/or vomiting (during the inpatient period), with laboratory-confirmed infection (with SMV specific primers on stool/emesis) or seroconversion
次要结局
- Area Under the Curve of SMV load(Day 1 to Day 21)
- Modified Vesikari Score (MVS) symptom scores during the inpatient period in infected patients(Day 1 to Day 6)
- Time to symptom improvement(Day 1 to Day 6)
- Time to first SMV-negative stool(Day 1 to Day 6)
- Incidence of treatment emergent adverse events(Day 0 to Day 21)
- Incidence of serious adverse events(From signing informed consent to Day 21)
- Time of maximum plasma concentration of CDI-988(Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours)
- Area under the plasma concentration time curve(Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours)
- Maximum plasma concentration of CDI-988(Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours)