A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers
2020年11月2日 更新者:Crinetics Pharmaceuticals Inc.
A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers
This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects.
This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
研究概览
研究类型
介入性
注册 (实际的)
57
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Western Australia
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Perth、Western Australia、澳大利亚、6009
- Linear Clinical Research
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only).
- Males and females subjects 65 to 85 years of age at screening (Part 3 only).
- Females must be non-pregnant and non-lactating, postmenopausal by history and confirmed by follicle stimulating hormone (FSH) >30 U/L at Screening, or surgically sterile.
- Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential.
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
- Willing to provide signed informed consent.
Exclusion Criteria:
- Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study.
- History or presence of malignancy within the past 5 years, not including treated basal cell carcinomas and in situ cervical neoplasia.
- Use of any investigational drug within the past 60 days.
- Have a medically significant abnormality observed during screening or admission.
- Use of any prior medication without approval of the investigator within 14 days prior to admission.
- Subjects with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections. Subjects with previous hepatitis C infection that is now cured may be eligible.
- History of or current alcohol or substance abuse in the past 12 months
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:单次递增剂量(第 1 部分)
|
安慰剂
安慰剂
Investigational drug
Investigational drug
|
实验性的:多次递增剂量(第 2 部分)
|
安慰剂
安慰剂
Investigational drug
Investigational drug
|
安慰剂比较:Elderly Cohort (Part 3)
|
安慰剂
安慰剂
Investigational drug
Investigational drug
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of participants with treatment emergent adverse events by severity
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Number of participants with serious adverse events (SAEs)
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
|
Number of participants with clinically significant changes in vital signs
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
|
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
|
Number of participants with ECG abnormalities
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Number of participants with clinical laboratory abnormalities
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pharmacokinetics (AUC)
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Assessment of the plasma area under the curve of CRN01941
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Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Pharmacokinetics (Cmax)
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Assessment of the maximum observed plasma concentration of CRN01941
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Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Pharmacokinetics (Tmax)
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Assessment of the time to reach Cmax for CRN01941
|
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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Pharmacokinetics (T1/2)
大体时间:Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
|
Assessment of the elimination half-life of CRN01941
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Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年4月29日
初级完成 (实际的)
2019年12月16日
研究完成 (实际的)
2019年12月16日
研究注册日期
首次提交
2019年4月25日
首先提交符合 QC 标准的
2019年5月2日
首次发布 (实际的)
2019年5月3日
研究记录更新
最后更新发布 (实际的)
2020年11月4日
上次提交的符合 QC 标准的更新
2020年11月2日
最后验证
2020年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CRN01941-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
安慰剂口服胶囊的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的