Oral CXA-10 Study in Healthy Volunteers
A Two-Part, Double-Blind, Third Party Open (Sponsor), Dose-Rising, Placebo-Controlled and Open-Label Exploratory Food Effect Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of CXA-10 in Healthy Volunteers
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Michigan
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Kalamazoo、Michigan、美国、49007
- Jasper Clinical Research & Development, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male subjects and female subjects of non-child bearing potential between the ages of 18 and 50 years (inclusive)
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 kg and 100 kg (inclusive)
- In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis. Subjects with blood pressures less than 150/95 mmHg at screening may be enrolled
- Subjects must have resting heart rates (HR) greater than or equal to 50 beats per minute at pre-dose
- QTcF interval (Fredericia's correction factor) must be less than or equal to 430 msec for males and less than or equal to 450 msec for females at screening and pre-dose. Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Subjects with a history of congenital long QT syndrome or in the subject's family will be excluded from the study (see Section 6.4)
- Adequate venous access to allow for repeated blood sampling
- Ability to comprehend and comply with procedures
- Agree to commit to participate in the current protocol
- Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
Exclusion Criteria:
- Female subjects who are pregnant or lactating or who are trying to conceive
- Females must not be of child bearing potential (defined as bilateral oophorectomy, hysterectomy, tubal ligation, or post-menopausal (amenorrhea for minimum of 1 year and post-menopausal status confirmed by follicle stimulating hormone (FSH) testing)). Female subjects unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal) must have this documented in the case report form (CRF)
- Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening or positive β-hCG urine at pre-dose
- Any clinically relevant abnormality identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
- Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason
- History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
- History of regular alcohol consumption exceeding 14 units/week for women or 21 units/week for men (one unit equal to 125 mL of wine or 284 mL of beer or a single 25 mL measure of spirits) within 6 months of screening
- History of smoking, including e-cigarettes, or use of nicotine-containing products within 1 month of screening
Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements) within 7 days or 5 half-lives, whichever is longer, prior to dosing and until collection of the final PK sample. Use of any drug including aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) must be avoided within 7 days prior to the first dose and during this study as it will interfere with the pharmacology of CXA-10. Use of high energy supplements or drinks (especially, those containing caffeine, protein supplements, and weight loss drugs) and smoking cessation products (gum, inhalers, patches, e cigarettes) will be prohibited
-Only acetaminophen will be permitted at doses of 2 grams/day
- Sitting blood pressure greater than 150 mmHg systolic and/or greater than 95 mmHg diastolic after 5 minutes rest (feet on floor, arm held at level of heart) at the screening visit
- Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
- Any abnormalities on 12-lead ECG at screening
- Any clinically significant murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)
- A positive urine drug screen for drugs of abuse, including alcohol or positive urine cotinine (greater than or equal to 300 ng/mL for cotinine) at the screening visit or at entry to the clinic (Note: urine cotinine required at screening visit only)
- Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
- Blood collection of greater than 500 mL within 56 days prior to screening
- Seropositive for human immunodeficiency virus (HIV) at screening
- Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening
- Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:CXA-10
single dose of CXA-10 oral formulation
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Part A has sequential single ascending doses will be administered in up to 5 cohorts of subjects.
Each cohort of subjects will be randomized to receive a single dose of CXA-10 or placebo in, a fasted state.
Part B has 2 periods and subjects will receive two doses of the selected dose of CXA-10.
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安慰剂比较:CXA-10 placebo
single oral doses of CXA-10 placebo
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of subjects with Serious and Non-Serious Adverse Events
大体时间:First day of dosing through 30 days after the last dose
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Safety assessments will be performed prior to, during, and after dosing including a visit on Day 18
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First day of dosing through 30 days after the last dose
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合作者和调查者
调查人员
- 首席研究员:Thomas Blok, MD、Jasper Clinic, Michigan
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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