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

NCT ID: NCT05389696

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2023-04-28

Brief Summary

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.

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.

Conditions

Heathly Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Part1. Group1. MIT-001 SC 10mg

Single subcutaneous administration of 10mg MIT-001 or placebo

Group Type: EXPERIMENTAL

Single subcutaneous administration and Blood collection

Intervention Type: DRUG

Single subcutaneous administration and Blood collection

Part1. Group2. MIT-001 SC 20mg

Single subcutaneous administration of 20mg MIT-001 or placebo

Group Type: EXPERIMENTAL

Single subcutaneous administration and Blood collection

Intervention Type: DRUG

Single subcutaneous administration and Blood collection

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

Group Type: EXPERIMENTAL

Single subcutaneous administration and then IV injection.

Intervention Type: DRUG

Single subcutaneous administration and then single intravenous administration after 2 weeks. In addition Blood collection is conducted as scheduled.

Part2. Group1: MIT-001 SC 20mg

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

Group Type: EXPERIMENTAL

MIT-001 20mg and 40mg_Multiple administration

Intervention Type: DRUG

Multiple subcutaneous administration for 7 days and then blood collection

Part2. Group2: MIT-001 SC 40mg

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

Group Type: EXPERIMENTAL

MIT-001 20mg and 40mg_Multiple administration

Intervention Type: DRUG

Multiple subcutaneous administration for 7 days and then blood collection

Interventions

Single subcutaneous administration and Blood collection

Single subcutaneous administration and Blood collection

Intervention Type: 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.

Intervention Type: DRUG

MIT-001 20mg and 40mg_Multiple administration

Multiple subcutaneous administration for 7 days and then blood collection

Intervention Type: DRUG

Other Intervention Names

MIT-001 10mg and 20mg; MIT-001 40mg; MIT-001 20mg and 40mg

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MitoImmune Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SeungHwan Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

Seoul National University

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MIT001-FD-SC01

Identifier Type: -

Identifier Source: org_study_id