Assessment of Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) Parameter Cmax
研究概览
简要总结
The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.
详细描述
This single-center, single ascending dose, phase I/IIa study was divided into 2 parts, involving both healthy subjects and patients with brain lesions:
- Study Part I included healthy subjects: double-blind, randomized, placebo control;
- Study Part II included patients with brain lesions: open-label.
In Part I, the following 6 dosing groups were investigated:
- Group 1: 0.025 mmol/kg
- Group 2: 0.05 mmol/kg
- Group 3: 0.075 mmol/kg
- Group 4: 0.1 mmol/kg
- Group 5: 0.2 mmol/kg
- Group 6: 0.3 mmol/kg
Healthy subjects were included and were then administered with P03277 or placebo and were to undergo MRI examination according to the randomization scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part I: Subjects between 18 and 45 years old (inclusive), with a body mass index (BMI) of 18 to 30 kg/m² (exclusive) and in a good health.
- •Part II: Patients 18 years old and older and having at least one brain lesion with a disruption of the blood brain barrier (BBB) and/or with abnormal vascularity in the brain. This/these lesion(s) must have been detected by previous imaging evaluation (Computed Tomography or MRI).
排除标准
- 未提供
研究组 & 干预措施
Part I (Phase I)
In each dose group (0.025, 0.05, 0.075, 0.1, 0.2 and 0.3 mmol/kg), 9 healthy subjects were to be included: 6 subjects received P03277 and 3 subjects received placebo in one single intravenous administration.
干预措施: P03277 (Drug)
Part I (Phase I)
In each dose group (0.025, 0.05, 0.075, 0.1, 0.2 and 0.3 mmol/kg), 9 healthy subjects were to be included: 6 subjects received P03277 and 3 subjects received placebo in one single intravenous administration.
干预措施: Placebo (Drug)
Part II (Phase IIA)
In each dose group (0.05, 0.075, 0.1 and 0.2 mmol/kg), all 3 patients received one single intravenous administration of P03277.
干预措施: P03277 (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Parameter Cmax
时间窗: From baseline (30 minutes before injection) to 24 hours post-injection
Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.
PK Parameter T1/2
时间窗: From baseline (30 minutes before injection) to 24 hours post-injection
T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.
PK Parameter Cl
时间窗: From baseline (30 minutes before injection) to 24 hours post-injection
Cl = total clearance. Blood samples were taken to assess the P03277 concentration.
PK Parameter Vd
时间窗: From baseline (30 minutes before injection) to 24 hours post-injection
Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.
次要结局
未报告次要终点