A Randomized, Single-blind, Placebo-controlled, Sequential Parallel-Group and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects
研究概览
简要总结
This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject
- •Are between the ages of 18 and 55 years (inclusive);
- •Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.
排除标准
- •Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- •Known or suspected malignancy;
- •Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
- •Positive pregnancy test result.
研究组 & 干预措施
KBP-7072: Cohort 1
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: KBP-7072 (Drug)
KBP-7072: Cohort 1
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: Placebo (Other)
KBP-7072: Cohort 2
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: KBP-7072 (Drug)
KBP-7072: Cohort 2
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: Placebo (Other)
KBP-7072: Cohort 3
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: KBP-7072 (Drug)
KBP-7072: Cohort 3
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: Placebo (Other)
KBP-7072: Cohort 4
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: KBP-7072 (Drug)
KBP-7072: Cohort 4
Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects
时间窗: up to 17 days
次要结局
- Area Under Curve (AUC) in healthy subjects(up to 10 days)