Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1. Group1. MIT-001 SC 10mg | Experimental | Single subcutaneous administration of 10mg MIT-001 or placebo |
|
| Part1. Group2. MIT-001 SC 20mg | Experimental | Single subcutaneous administration of 20mg MIT-001 or placebo |
|
| 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 |
|
| Part2. Group1: MIT-001 SC 20mg | Experimental | Multiple subcutaneous administration of 20mg MIT-001/day or placebo for 7days |
|
| Part2. Group2: MIT-001 SC 40mg | Experimental | Multiple subcutaneous administration of 40mg MIT-001/day or placebo for 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single subcutaneous administration and Blood collection | Drug | Single subcutaneous administration and Blood collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK_Cmax_Part1 Group 1&2 | Part 1, Group 1,2: Cmax | Part1. Group 1&2: Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_Cmax_Part1 Group 3 | Part 1, Group 3: Cmax | 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. |
| PK_AUClast_Part1 Group 1&2 | Part1, Group 1&2: AUClast | Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_AUClast_Part1 Group 3 | Part 1, Group 3: AUClast | 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. |
| PK_AUCinf_Part 1, Group 1&2 | Part 1, Group 1&2: AUCinf | Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_AUCinf_Part 1, Group 3 | Part 1, Group 3: AUCinf | 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. |
| PK_Tmax_Part 1, Group 1&2 | Part 1, Group 1&2: Tmax |
Not provided
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee, MD | Seoul National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University | Seoul | 03080 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Single subcutaneous administration and then IV injection. | Drug | Single subcutaneous administration and then single intravenous administration after 2 weeks. In addition Blood collection is conducted as scheduled. |
|
|
| MIT-001 20mg and 40mg_Multiple administration | Drug | Multiple subcutaneous administration for 7 days and then blood collection |
|
|
| Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_Tmax_Part 1, Group 3 | Part 1, Group 3: Tmax | 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. |
| PK_t1/2_Part 1, Group 1&2 | Part 1, Group 1&2: t1/2 | Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_t1/2_Part 1, Group 3 | Part 1, Group 3: t1/2 | 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. |
| PK_Vd/F_Part 1, Group 1&2 | Part 1, Group 1&2: Vd/F | Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_Vd/F_Part 1, Group 3 | Part 1, Group 3: Vd/F | 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. |
| PK_CL/F_Part 1, Group 1,2 | Part 1, Group 1,2: CL/F | Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_CL/F_Part 1, Group 3 | Part 1, Group 3: CL/F | 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. |
| PK_MRT_Part 1, Group 1&2 | Part 1, Group 1,2: MRT | Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_MRT_Part 1, Group 3 | Part 1, Group 3: MRT | 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. |
| PK_F_Part1, Group1,2 | Part 1, Group 1,2: F | Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points. |
| PK_F_Part1, Group3 | Part 1, Group 3: F | 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. |
| PK_Part2_Cmax | Part 2: Cmax | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Cmin | 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 | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Cavg | Part 2: Cavg | Par2_Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_AUCtau | Part 2: AUCtau | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Tmax | Part 2: Tmax | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_t1/2 | Part 2: t1/2 | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Vd/F | Part 2: Vd/F | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_CL/F | Part 2: CL/F | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Cmax,ss | Part 2: Cmax,ss | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Cmin,ss | Part 2: Cmin,ss | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Cavg,ss | Part 2: Cavg,ss | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_AUCtau,ss | Part 2: AUCtau,ss | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Tmax,ss | Part 2: Tmax,ss | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_t1/2,ss | Part 2: _t1/2,ss | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Vdss/F | Part 2: _Vdss/F | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_CLss/F | Part 2: _VCLss/F | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_PTF | Part 2: _PTF | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |
| PK_Part2_Rac | Part 2: _Rac | Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points |