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

NCT05389696 | Completed Phase 1 DMC

• 1 other identifier: MIT001-FD-SC01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Heathly Subjects

Outcome Measures

Primary Outcomes (36)

• 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

Study Arms (5)

Part1. Group1. MIT-001 SC 10mg

EXPERIMENTAL

Single subcutaneous administration of 10mg MIT-001 or placebo

Drug: Single subcutaneous administration and Blood collection

Part1. Group2. MIT-001 SC 20mg

EXPERIMENTAL

Single subcutaneous administration of 20mg MIT-001 or placebo

Drug: Single subcutaneous administration and Blood collection

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

Drug: Single subcutaneous administration and then IV injection.

Part2. Group1: MIT-001 SC 20mg

EXPERIMENTAL

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

Drug: MIT-001 20mg and 40mg_Multiple administration

Part2. Group2: MIT-001 SC 40mg

EXPERIMENTAL

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

Drug: MIT-001 20mg and 40mg_Multiple administration

Interventions

Single subcutaneous administration and Blood collection DRUG

Single subcutaneous administration and Blood collection

Also known as: MIT-001 10mg and 20mg

Part1. Group1. MIT-001 SC 10mg; Part1. Group2. MIT-001 SC 20mg

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.

Also known as: MIT-001 40mg

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

MIT-001 20mg and 40mg_Multiple administration DRUG

Multiple subcutaneous administration for 7 days and then blood collection

Also known as: MIT-001 20mg and 40mg

Part2. Group1: MIT-001 SC 20mg; Part2. Group2: MIT-001 SC 40mg

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MitoImmune Therapeutics: lead

Study Sites (1)

Seoul National University

Seoul, 03080, South Korea

Location

Study Officials

• SeungHwan Lee, MD

  Seoul National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 25, 2022
• Study Start: May 13, 2022
• Primary Completion: February 13, 2023
• Study Completion: April 28, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)