NCT00922324已完成1 期
A Single-Center Randomized, Double-Blind, Placebo-Controlled Phase 1 Trial to Assess the Safety and Tolerability of Single and Multiple Daily Oral Administration of STP206 Live Biotherapeutic in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The study will assess the safety, tolerability and fecal shedding of STP206 when given as a single dose and when given as daily doses for one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, 18 - 55 years of age
- •In general good heath as established by medical history, physical examination, and laboratory assessment
- •The subject is willing and able to comply with the protocol and complete all visits and procedures
- •Provide written informed consent after the nature of the study has been explained
排除标准
- •Subjects with any chronic illness or conditions that require treatment
- •Subjects with clinically significant abnormal laboratory values noted during the screening laboratory evaluation
- •Subjects with history of immune compromised conditions or any past use of immunosuppressant treatment
- •Subjects with current or past history of gastrointestinal disease, including any conditions with increased risk for bleeding (e.g., gingivitis, hemorrhoids)
- •Subjects who are lactose intolerant
- •Subjects who are intolerant or allergic to Splenda® or any of its ingredients (dextrose, maltodextrin, sucralose) or have a soy allergy
- •Subjects who have had a fever of 100°F or higher within the 2 weeks of the first dose of study drug
- •Subjects who have received a "live" vaccine within 30 days of the first dose of study drug
- •Subjects who have received any medications (prescription or OTC) within 2 weeks of the first dose of study drug
- •Subjects who have received and investigational drug with 30 days prior to the first dose of study drug
- •Subjects with a history of illicit drug use or alcohol abuse
- •Subjects with any other medical condition that may influence the objectives or outcomes of the study
- •Female subjects who are pregnant or lactating
- •Female subjects of childbearing potential who are not using an FDA approved birth control method
- •Subjects who are healthcare or daycare providers or those with close contact with immune compromised individuals
- •Subjects with a history of acute hepatitis, HIV infection or known to have positive diagnostic tests for HIV or HBV
- •Subjects who have a planned dental appointment from screening through 7 days after last dose of Investigational Product.
研究组 & 干预措施
STP206
Experimental
STP206 administered either as a single dose or as a daily dose for seven consecutive days
干预措施: STP206 or vehicle control (Drug)
Vehicle Control
Placebo Comparator
STP206 vehicle administered as either a single dose or as a daily dose for 7 consecutive days
干预措施: STP206 or vehicle control (Drug)
结局指标
主要结局
Adverse events
时间窗: 7-days post dosing and 30-days post dosing
Changes in physical examination findings
时间窗: 7-days post dosing
Changes in laboratory (hematology, chemistry, and urinalysis) variables
时间窗: 7-days post dosing
次要结局
- Fecal Shedding of STP206 components(30 days post dosing)
研究者
研究点 (1)
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