The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
MEX3B is an RNA-binding protein that is conserved in many animal species and has wide range of biological function. The MEX3B protein is deeply involved in the expression of various cytokines associated with the onset and exacerbation of several diseases such as inflammatory diseases, metabolic diseases, and malignant tumors. TAKC-02 is a nucleic acid medicine, antisense oligonucleotide, inhibits the MEX3B synthesis expected to have potential as new medication.
This plans to evaluate the safety profile of the inhalation solution in order to develop TAKC-02 for severe asthma.
The study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TAKC-02 in healthy male subjects. The study is a Single Ascending Dose (Step 1) followed by a Multiple Comparative Dose (Step 2).
研究概览
详细说明
This initial Phase I study will be conducted in normal healthy male volunteers to obtain an unconfounded understanding of the safety, tolerability and pharmacokinetics of TAKC-02 inhalation solution. TAKC-02 is being developed as a medication for uncontrolled severe asthma. The first-in-human, randomized, double-blind trial will evaluate single ascending doses (SAD) and subsequently multiple ascending doses (MAD) of TAKC-02 and placebo.
Step 1 (SAD) :
There will be 5 cohort of 6 (Cohort 1, 2, 3) or 8 (Cohort 4, 5) subjects each. Subjects in each cohort are randomized in a 2:1 ratio (Cohort 1, 2, 3) and 3:1 ratio to receive a single dose of the study drugs, TAKC-02 or Placebo. The SAD study will evaluate the safety and tolerability of a single dose of TAKC-02 and determine the starting and maximum doses for Step 2. Pharmacokinetics will be also analyzed. One cohort (cohort 4.5) maybe added depending on the incidence of adverse effect in the lower dosing group.
Step 2 There will be 2 cohort f 8 subjects each. Subjects in both cohorts are randomized in a 3:1 ratio to receive multiple doses of the study drugs, TAKC-02 or Placebo. The safety and tolerability of repeated administration of TAKC-02 for 2 weeks will be evaluated, and the maximum dose of this drug in the next phase will be estimated. Pharmacokinetics will be also analyzed.
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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Tokyo、日本
- TAKC-02 Study Site
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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:
Both Step 1 and Step 2 are for healthy adult males who meet all of the following conditions.
- Subjects are normal healthy men
- Aged between 20 and 40 at the time of consent
- Subjects who have obtained the voluntary consent of the person in writing
- Subjects with BMI of 18.5 or more and less than 25.0 kg / m2
- Subjects who can be hospitalized during the cohort transition safety assessment period
Exclusion Criteria:
Both Step 1 and Step 2 do not apply to those who meet any of the following conditions.
- Subjects with clinically problematic complications or medical history
- Subjects with a history of drug allergies
- Smokers (those who have smoked within 1 year)
- Subjects with hypersensitivity disease (excluding asymptomatic pollinosis)
- Those who may affect the absorption, distribution, metabolism and excretion of drugs
- Subjects have been prescribed a drug intended for treatment within 4 weeks before administration of the study drug, or those who need administration during the period of participation in the study
- Subjects have used over-the-counter drugs within 4 weeks before administration of the study drug, or those who need to use it during the period of participation in the study
- Subjects ingested alcoholic beverages or caffeine-containing beverages within 24 hours before administration of the study drug
- Subjects with reduced lung function (FEV1.0% <70%)
- Subjects with alcoholism or drug addiction
- Subjects have a positive reaction in the substance abuse test
- Subjects tested positive for HBsAg, hepatitis C virus (HCV) antibody, HIV antigen / antibody, syphilis serum reaction or severe acute respiratory syndrome (SARS)-CoV-2 nucleic acid amplification
- Subjects collected 400 mL or more of whole blood within 16 weeks before administration of the study drug or 200 mL or more of blood within 4 weeks, or those who collected component blood (plasma component and platelet component) within 2 weeks before administration of the study drug, or subjects whose annual total blood collection volume exceeds 1200 mL, including the planned blood collection volume for clinical trials
- Subjects have been treated with TAKC-02 in the past
- Subjects participated in another clinical trial and were administered anther test drug within 16 weeks before the administration of the study drug, or those who participated in another clinical trial at the same time as this clinical trial.
- Subjects have been vaccinated against new coronavirus, influenza, etc. within 4 weeks before the administration of the study drug, or who are scheduled to be vaccinated during the period of participation in the study.
- Subjects are not willing to adhere to proper contraception using effective contraception for 3 weeks after the last dose of the study drug from the date of admission of study site.
- Subjects are judged inappropriate to participate in the clinical trial by the investigator or the co-investigator.
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: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:Cohort 1
TAKC-02 0.15mg Single dose
|
Inhalation Solution
|
安慰剂比较:Placebo (to Cohort 1)
|
吸入溶液
|
实验性的:Cohort 2
TAKC-02 0.5mg Single dose
|
Inhalation Solution
|
安慰剂比较:Placebo (to Cohort 2)
|
吸入溶液
|
实验性的:Cohort 3
TAKC-02 1.5mg Single dose
|
Inhalation Solution
|
安慰剂比较:Placebo (to Cohort 3)
|
吸入溶液
|
实验性的:Cohort 4
TAKC-02 5mg Single dose
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Inhalation Solution
|
安慰剂比较:Placebo (to Cohort 4)
|
吸入溶液
|
实验性的:Cohort 5
TAKC-02 15mg Single dose
|
Inhalation Solution
|
安慰剂比较:Placebo (to Cohort 5)
|
吸入溶液
|
实验性的:Cohort 6
TAKC-02 Multiple dose (low)
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Inhalation Solution
|
安慰剂比较:Placebo (to Cohort 6)
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吸入溶液
|
实验性的:Cohort 7
TAKC-02 Multiple dose (high)
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Inhalation Solution
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安慰剂比较:Placebo (to Cohort 7)
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吸入溶液
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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 |
---|---|---|
Changes in the rate of adverse events
大体时间:Up to 7 days after dose
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assessed by the change in number of adverse events
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Up to 7 days after dose
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次要结果测量
结果测量 |
大体时间 |
---|---|
AUC from time zero to the time of the last quantifiable concentration (AUC0-t last)
大体时间:Up to 48 hours after last dose
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Up to 48 hours after last dose
|
Cmax
大体时间:Up to 48 hours after last dose
|
Up to 48 hours after last dose
|
Tmax
大体时间:Up to 48 hours after last dose
|
Up to 48 hours after last dose
|
T1/2
大体时间:Up to 48 hours after last dose
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Up to 48 hours after last dose
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TAKC-02-001
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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安慰剂的临床试验
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的