CompletedPhase 1

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

South Korea40 participantsStarted 2022-05-13

Plain-language 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.

Who can participate

Age range19 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✓. 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

✕. 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

What they're measuring

PK_Cmax_Part1 Group 1&2

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

PK_Cmax_Part1 Group 3

Timeframe: 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

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

PK_AUClast_Part1 Group 3

Timeframe: 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

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

PK_AUCinf_Part 1, Group 3

Timeframe: 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

Trial details

NCT IDNCT05389696

SponsorMitoImmune Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-13

View on ClinicalTrials.gov More Heathly Subjects trials

Plain-language summary

Who can participate

Age range19 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✓. 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

✕. 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

What they're measuring

PK_Cmax_Part1 Group 1&2

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

PK_Cmax_Part1 Group 3

Timeframe: 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

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

PK_AUClast_Part1 Group 3

Timeframe: 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

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

PK_AUCinf_Part 1, Group 3

Timeframe: 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