A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Effects After a Single Dose of VBP15
研究概览
简要总结
The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
- •For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.
排除标准
- •For the MAD Study: Women of childbearing potential.
- •Clinically significant abnormal laboratory parameters
研究组 & 干预措施
VBP15- 0.1 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 0.3 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 1.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 3.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 8.0 mg/kg Fasting SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 8.0 mg/kg Fed SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high high calorie meal.
干预措施: VBP15 (Drug)
VBP15- 20.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
干预措施: VBP15 (Drug)
Placebo - SAD
Subjects were orally administered a placebo under fasted conditions.
干预措施: Placebo (Drug)
VBP15- 1.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 3.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 9.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions.
干预措施: VBP15 (Drug)
VBP15- 20.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions.
干预措施: VBP15 (Drug)
Placebo MAD
Subjects were orally administered placebo for 14 days under fasted conditions.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Adverse Effects After a Single Dose of VBP15
时间窗: Participants will be followed for the duration of hospital stay of 4 days
Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)
时间窗: Participants will be followed for the duration of hospital stay of 4 days
Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15
时间窗: Participants will be followed for the duration of hospital stay of 4 days
Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15
时间窗: Participants will be followed for the duration of hospital stay of 15 days
Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)
时间窗: Participants will be followed for the duration of hospital stay of 15 days
Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15
时间窗: Participants will be followed for the duration of hospital stay of 15 days
次要结局
未报告次要终点