NCT00717262已完成1 期
A Phase 1, Double-Blind, Placebo Controlled, Repeat-Dose Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
研究概览
简要总结
The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if there are differences in these parameters when HQK-1001 is administered in a fed versus a fasted state.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female
- •Between the ages of 18 and 45 years old
- •Able and willing to give informed consent
- •Able to comply with all study procedures
- •If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and throughout the study: hormonal (i.e., oral, transdermal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (6 months minimum); or abstinence
- •Male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate, throughout the course of the study
- •Not receiving medications within the 2 weeks before the first dose of study medication, except for multivitamins and contraception
- •Complete blood count (CBC) with white blood cell (WBC) count hemoglobin, hematocrit, reticulocyte count and platelet count within normal range for the testing facility or not clinically significant
- •Serum ferritin level > 50 ng/ml in Cohort 1
- •Serum ferritin level > 30 mg/ml in Cohorts 2, 3, 4 and 5
- •Serum chemistry values, coagulation tests and urinalysis values within the normal range for the testing facility or not clinically significant
- •Negative urine test for substances of abuse including marijuana, cocaine, opiates, and methadone
排除标准
- •Prior participation in HQP 2007-001
- •Clinically significant abnormal vital signs
- •Blood donation within 2 months of study medication administration
- •Blood transfusion within 3 months of study medication administration
- •An acute febrile illness or upper respiratory tract illness within 72 hours prior to administration of study medication
- •Received another investigational agent within 4 weeks before administration of study medication
- •Receiving any other investigational agent during this study
- •Any acute or chronic disease (e.g., history of hepatitis B or C or HIV-1)
- •Heart disease including an abnormal electrocardiogram, clinical significant, (ECG) or cardiac arrhythmia
- •History of neurological disease, such as a seizure disorder
- •Currently pregnant or breast feeding a child
- •A smoker in the past 12 months
- •Body Mass Index (BMI) >33 kg/m2
研究组 & 干预措施
1
Experimental
HQK-1001
干预措施: HQK-1001 (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
时间窗: 41 days
次要结局
- Pharmacokinetics assessed by plasma drug concentration levels(15 days)
- Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin(41 days)
- Comparison of safety, PK and PD under fed versus fasting conditions(41 days)
- Comparison of safety and PK when oral iron is administered with HQK-1001.(41 days)
研究者
研究点 (1)
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