A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adverse Event related to XG005
研究概览
简要总结
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.
详细描述
This is a randomized, double-blind, placebo-controlled study which will investigate the PK, safety, and tolerability of four ascending single and multiple oral doses of XG005 in healthy subjects. The trial consists of two parts: a single ascending dose (SAD) PK evaluation (Part 1) and a multiple ascending dose (MAD) PK evaluation (Part 2). Approximately 32 Subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Investigator or designee, study coordinator(s), subjects, the Sponsor study team and its representatives, will be blinded to the treatment assignment.
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 males or females between 18 and 55 years of age
- •BMI 18.0 to 30.0 kg/m2
- •Non-pregnant, non-breastfeeding female subjects
排除标准
- •Unstable or severe illness
- •History of, or current treatment for, GI disease
- •Clinically significant history of medical condition associated with GI events
- •History of or current glucose intolerance or gestational diabetes
- •Lifetime history of suicidal behavior
- •Creatinine clearance < 90 mL/min
- •Any elevation of liver function tests
- •Creatine kinase (CK) value of greater than 1.5 times the upper limit
- •Leucocytes or lymphocytes less than 1.5 times the lower limit of normal
- •Positive Hepatitis B surface antigen, HCV, or HIV
研究组 & 干预措施
XG005
XG005 in 4 dose levels
干预措施: XG005 (Drug)
Placebo
Placebo in all cohort
干预措施: Placebos (Drug)
结局指标
主要结局
Adverse Event related to XG005
时间窗: Day 1 to 7 days after last dose
Adverse Event reported as mild, moderate, severe on physical exam, ECG and laboratory results
次要结局
未报告次要终点