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临床试验/NCT05389696
NCT05389696已完成1 期

Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of MIT-001 After Subcutaneous and Intravenous Administration in Healthy Subjects

MitoImmune Therapeutics1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月13日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
PK_AUCinf_Part 1, Group 1&2
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. Part 1 Randimization, Double blinded, Placebo controlled, Dose escalation(10mg, 20mg, 40mg) of MIT-001 SC or IV single administration to evaluate safety, tolerability and PK in healthy adult.
  2. Part2 Randimization, Double blinded, Placebo controlled, MIT-001 SC multiple administration for 7days (20mg & 40mg) to evaluate safety, tolerability and PK in healthy adult.

详细描述

This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple dose, dose escalation clinical trial in 40 healthy subjects. This study consists of part 1(single dose for group 1, 2, 3) and part 2(multiple dose for 7 days to group 1 and 2). Subjects will be assigned in 6:2 allocation to receive active or placebo treatments. The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic properties of MIT-001 after single and multiple subcutaneous administration in healthy adults and to compare IV administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 45 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •A healthy adult between 19 and 45 at the time of screening
  • •A person who weigh 55.0 kg or more and 90.0 kg or less at the time of screening and have a body mass index (BMI) of 18.0 or more and 27.0 or less
  • •☞ BMI (kg/m2) = Weight (kg) / {Height (m)}2
  • •A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and consents in writing before the screening procedure
  • •A person suitable as a test subject for this study when judged by the investigator through physical examination, clinical laboratory examination, questionnaire, etc.

排除标准

  • •Clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system disease, blood/tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or a history of above diseases
  • •A person with a history of hypersensitivity or clinically significant hypersensitivity to clinical investigational drugs, drugs containing the same class of ingredients, and other drugs (aspirin, antibiotics, etc.)
  • •At screening, QTc > 450 ms on ECG or other clinically significant findings
  • •A person with AST and ALT exceeding 1.5 times the upper limit of the normal range during screening
  • •A person with eGFR of less than 60 mL/min/1.73m2 measured using the CKD EPI formula in clinical laboratory tests at screening
  • •At screening, systolic blood pressure > 160 mmHg or < 90 mmHg, or diastolic blood pressure > 100 mmHg or < 50 mmHg
  • •A person with a history of drug abuse or who have tested positive for drugs of abuse in urine drug screening tests
  • •A person who has taken any prescription drugs or herbal medicines within 2 weeks before the first scheduled administration date, or have taken any over-the-counter (OTC), health functional food, or vitamin preparations within 1 week In cases where it is reasonable, they can participate in the clinical trial) or those who are expected to take it
  • •A person who has taken drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first scheduled administration date
  • •A person who has participated in other clinical trials or bioequivalence studies within 6 months prior to the scheduled first administration date and received the investigational drug or bioequivalence study drug
  • •A person who has donated whole blood within 2 months before the first scheduled dose or donated component blood within 1 month, or received blood transfusion within 1 month before the first scheduled dose
  • •A person who continuously drinks alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol (≒ 1 glass of soju or 250 mL of beer)) or cannot abstain from alcohol during the clinical trial period
  • •Smokers (However, if you quit smoking 3 months before the first scheduled dose, you can be selected as a test subject)
  • •A person who has consumed caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated drinks, coffee milk, nourishing drinks, etc.) within 24 hours of hospitalization for clinical trials and those who cannot refrain from consuming them during hospitalization
  • •A person who does not use the following medically acceptable contraceptive methods for 1 month from participation in the clinical trial to the last administration of the investigational drug A. Use of an intrauterine device (copper loop, hormone-containing intrauterine system) with a proven rate of pregnancy failure in the spouse (or partner) B. Concomitant use of either a spermicide or a parenteral hormonal contraceptive with a barrier contraceptive method (male or female) C. Surgery of you or your partner (vasectomy, fallopectomy/ligation, hysterectomy, etc.) D. Use of a cervical cap or contraceptive diaphragm with a male condom
  • •Pregnant or lactating women
  • •A person who judged the investigator to be inappropriate to participate in the clinical trial due to other reasons

研究组 & 干预措施

Part1. Group1. MIT-001 SC 10mg

Experimental

Single subcutaneous administration of 10mg MIT-001 or placebo

干预措施: Single subcutaneous administration and Blood collection (Drug)

Part1. Group2. MIT-001 SC 20mg

Experimental

Single subcutaneous administration of 20mg MIT-001 or placebo

干预措施: Single subcutaneous administration and Blood collection (Drug)

Part1. Group3. MIT-001 SC 40mg and IV 40mg

Experimental

Single subcutaneous administration of 40mg MIT-001 or placebo and then signle intravenous administration of 40mg MIT-001 or placebo

干预措施: Single subcutaneous administration and then IV injection. (Drug)

Part2. Group1: MIT-001 SC 20mg

Experimental

Multiple subcutaneous administration of 20mg MIT-001/day or placebo for 7days

干预措施: MIT-001 20mg and 40mg_Multiple administration (Drug)

Part2. Group2: MIT-001 SC 40mg

Experimental

Multiple subcutaneous administration of 40mg MIT-001/day or placebo for 7days

干预措施: MIT-001 20mg and 40mg_Multiple administration (Drug)

结局指标

主要结局

PK_AUCinf_Part 1, Group 1&2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1\&2: AUCinf

PK_Tmax_Part 1, Group 1&2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1\&2: Tmax

PK_t1/2_Part 1, Group 1&2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1\&2: t1/2

PK_Cmax_Part1 Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: Cmax

PK_Cmax_Part1 Group 1&2

时间窗: Part1. Group 1&2: Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1,2: Cmax

PK_Vd/F_Part 1, Group 1&2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1\&2: Vd/F

PK_CL/F_Part 1, Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: CL/F

PK_MRT_Part 1, Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: MRT

PK_F_Part1, Group1,2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1,2: F

PK_Part2_Cavg

时间窗: Par2_Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Cavg

PK_Part2_t1/2

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: t1/2

PK_Part2_Tmax,ss

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Tmax,ss

PK_Part2_CLss/F

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: _VCLss/F

PK_AUClast_Part1 Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: AUClast

PK_t1/2_Part 1, Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: t1/2

PK_Vd/F_Part 1, Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: Vd/F

PK_F_Part1, Group3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: F

PK_Part2_Tmax

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Tmax

PK_Part2_AUCtau,ss

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: AUCtau,ss

PK_AUClast_Part1 Group 1&2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part1, Group 1\&2: AUClast

PK_Tmax_Part 1, Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: Tmax

PK_Part2_Cmax

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Cmax

PK_Part2_Cmin

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Cmin, Cavg, AUCtau, Tmax, t1/2, Vd/F, CL/F, Cmax,ss, Cmin,ss, Cavg,ss, AUCtau,ss, Tmax,ss, t1/2,ss, Vdss/F, CLss/F, PTF, Rac

PK_Part2_Cmax,ss

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Cmax,ss

PK_Part2_Cavg,ss

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Cavg,ss

PK_Part2_PTF

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: _PTF

PK_AUCinf_Part 1, Group 3

时间窗: Part1. Group 3_Before SC administration(Day0, 0hour) to 144hour 16 points and then Before IV administration on 15th day(0hour) to 144hour after IV administration 17points.

Part 1, Group 3: AUCinf

PK_CL/F_Part 1, Group 1,2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1,2: CL/F

PK_MRT_Part 1, Group 1&2

时间窗: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.

Part 1, Group 1,2: MRT

PK_Part2_t1/2,ss

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: _t1/2,ss

PK_Part2_Rac

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: _Rac

PK_Part2_AUCtau

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: AUCtau

PK_Part2_Vd/F

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Vd/F

PK_Part2_CL/F

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: CL/F

PK_Part2_Cmin,ss

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: Cmin,ss

PK_Part2_Vdss/F

时间窗: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points

Part 2: _Vdss/F

次要结局

未报告次要终点

研究者

发起方
MitoImmune Therapeutics
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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