Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC Administration in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Heathly Subjects
• Intervention / Treatment: Drug: Single subcutaneous administration and Blood collection; Drug: Single subcutaneous administration and then IV injection.; Drug: MIT-001 20mg and 40mg_Multiple administration

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. A healthy adult between 19 and 45 at the time of screening

2. 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

3. 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
4. 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:

1. 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
2. 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.)
3. At screening, QTc > 450 ms on ECG or other clinically significant findings
4. A person with AST and ALT exceeding 1.5 times the upper limit of the normal range during screening
5. A person with eGFR of less than 60 mL/min/1.73m2 measured using the CKD EPI formula in clinical laboratory tests at screening
6. At screening, systolic blood pressure > 160 mmHg or < 90 mmHg, or diastolic blood pressure > 100 mmHg or < 50 mmHg
7. A person with a history of drug abuse or who have tested positive for drugs of abuse in urine drug screening tests
8. 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
9. 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
10. 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
11. 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
12. 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
13. Smokers (However, if you quit smoking 3 months before the first scheduled dose, you can be selected as a test subject)
14. 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
15. 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
16. Pregnant or lactating women
17. A person who judged the investigator to be inappropriate to participate in the clinical trial due to other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part1. Group1. MIT-001 SC 10mg; Single subcutaneous administration of 10mg MIT-001 or placebo	Drug: Single subcutaneous administration and Blood collection; Single subcutaneous administration and Blood collection; Other Names: MIT-001 10mg and 20mg
Experimental: Part1. Group2. MIT-001 SC 20mg; Single subcutaneous administration of 20mg MIT-001 or placebo	Drug: Single subcutaneous administration and Blood collection; Single subcutaneous administration and Blood collection; Other Names: MIT-001 10mg and 20mg
Experimental: Part1. Group3. MIT-001 SC 40mg and IV 40mg; Single subcutaneous administration of 40mg MIT-001 or placebo and then signle intravenous administration of 40mg MIT-001 or placebo	Drug: Single subcutaneous administration and then IV injection.; Single subcutaneous administration and then single intravenous administration after 2 weeks. In addition Blood collection is conducted as scheduled.; Other Names: MIT-001 40mg
Experimental: Part2. Group1: MIT-001 SC 20mg; Multiple subcutaneous administration of 20mg MIT-001/day or placebo for 7days	Drug: MIT-001 20mg and 40mg_Multiple administration; Multiple subcutaneous administration for 7 days and then blood collection; Other Names: MIT-001 20mg and 40mg
Experimental: Part2. Group2: MIT-001 SC 40mg; Multiple subcutaneous administration of 40mg MIT-001/day or placebo for 7days	Drug: MIT-001 20mg and 40mg_Multiple administration; Multiple subcutaneous administration for 7 days and then blood collection; Other Names: MIT-001 20mg and 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: MitoImmune Therapeutics
• Investigators: Principal Investigator: SeungHwan Lee, MD, Seoul National University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MIT001-FD-SC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No