A Phase I Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.
研究概览
简要总结
This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This study is to be conducted at two clinical centers and in conformity with Good Clinical Practice (GCP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each subject must be willing and able to provide written informed consent for the study
- •Healthy volunteer subjects of both genders, aged 18-64 years old, and any race/ethnicity
- •Subjects with normal blood pressure (between ranges of 120-140/60-80 mmHg) at screening and baseline
- •Subjects with a body mass index (BMI) 18-30 kg/m2
- •Men or woman of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during screening, while receiving the investigational drug, and for 60 days after stopping the investigational drug
- •Female subjects of childbearing potential must have a negative urine pregnancy test at screening
- •Subjects with physiological examination and laboratory values within normal limits (CBC/differential, blood chemistry, iron, Total Iron Binding Capacity (TIBC), urinalysis, ECG and vital signs)
- •Subjects with the ability to comprehend and complete the telephone visits, screening, and site visits
- •Subjects must be able to adhere to dose and visit schedules
- •Subjects who agree to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial.
排除标准
- •Subjects with any allergic reaction or sensitivity to glutamate acid, polyethylene glycol, or any component of the test article product
- •Subjects who consume > five alcoholic beverages per week
- •Subjects who are pregnant or lactating
- •Subjects who have blood (or urine) levels outside the normal range for any hepatic, renal, hematologic, lipid or coagulation parameters measured.
- •Subjects on Hormone Replacement Therapy within the past three months
- •Subjects in any other clinical trial or experimental treatment in the past three months
- •Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, hypertension, hypotension or systolic blood pressure below 80 mmHg, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.
研究组 & 干预措施
RadProtect®
RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine. Transferrin and other related proteins can chelate with ferrous iron and break the micelle releasing amifostine into the blood stream.
干预措施: RadProtect® (Drug)
结局指标
主要结局
Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.
时间窗: Day 0~ Day 28
DLT is defined as a subject's symptom worse than a Grade 2, with the exception of the value for Total Protein and Cholesterol that should be determined by the investigator as these values may be affected by diet and there may be no discomfort or immediate risk for subjects. During the telephone visits on Day 3, 14+2, and 28+2 after injection, the study coordinator will confirm the subject's status, report to the investigators, and will schedule extra hospital visits if necessary.
次要结局
- Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points.(Day 0 ~ Day 1 (24 hours after dosing))