NCT00936429已完成1 期
Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
研究概览
简要总结
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.
详细描述
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females age 18 to
- •Body weight ≥ 110 pounds (50 kg).
- •Satisfactory medical condition established by medical history and physical examination.
- •Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception.
排除标准
- •Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
- •Abuse of drugs or alcohol within 12 months prior to screening.
- •Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •Receipt of any vaccination within 30 days prior to screening.
- •Receipt of blood products within 6 months of screening.
- •Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period.
- •History of flavivirus infection.
- •No easy access to a fixed or mobile telephone.
- •History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of > 1 year.
- •Donation of ≥ 450 mL of blood within the previous 12 weeks.
结局指标
主要结局
To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
时间窗: Assessed at each study visit
次要结局
- To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses(Every 2 weeks during treatment)
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy SubjectsGastrointestinal Motility DisorderNCT01644240Theravance Biopharma16
已完成
1 期
A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy SubjectsHealthy VolunteersNCT05103878Bacainn Therapeutics, Inc.50
已完成
1 期
Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003Healthy VolunteersNCT01992367ASLAN Pharmaceuticals61
已完成
1 期
Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy VolunteersHealthyNCT02796131Ardelyx105
已完成
1 期
A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)Healthy Adult SubjectsNCT04979572Taisho Pharmaceutical Co., Ltd.41