Heathly SubjectsPhase 1NCT05389696
Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC Administration in Healthy Subjects
A Phase 1 study testing Single subcutaneous administration and Blood collection, Single subcutaneous administration and then IV injection. and MIT-001 20mg and 40mg_Multiple administration in people with Heathly Subjects, run by MitoImmune Therapeutics at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathly Subjects
- What is being tested?
- Single subcutaneous administration and Blood collection, Single subcutaneous administration and then IV injection. and MIT-001 20mg and 40mg_Multiple administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2022to 28 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- Pregnant or lactating women
- A person who judged the investigator to be inappropriate to participate in the clinical trial due to other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of MIT-001 After Subcutaneous and Intravenous Administration in Healthy Subjects
- 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.
- Part2 Randimization, Double blinded, Placebo controlled, MIT-001 SC multiple administration for 7days (20mg \& 40mg) to evaluate safety, tolerability and PK in healthy adult.
Read the 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
- Being tested
- Single subcutaneous administration and Blood collection, Single subcutaneous administration and then IV injection., MIT-001 20mg and 40mg_Multiple administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single subcutaneous administration and Blood collectionDrug
Also called MIT-001 10mg and 20mg
Single subcutaneous administration and Blood collection
Single subcutaneous administration and then IV injection.Drug
Also called MIT-001 40mg
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 administrationDrug
Also called MIT-001 20mg and 40mg
Multiple subcutaneous administration for 7 days and then blood collection
| Study group | Role | What they receive |
|---|---|---|
| Part1. Group1. MIT-001 SC 10mg | Experimental | Single subcutaneous administration of 10mg MIT-001 or placebo Receives: Drug: Single subcutaneous administration and Blood collection |
| Part1. Group2. MIT-001 SC 20mg | Experimental | Single subcutaneous administration of 20mg MIT-001 or placebo Receives: 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 Receives: 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 Receives: 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 Receives: Drug: MIT-001 20mg and 40mg_Multiple administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK_Cmax_Part1 Group 1&2
Part 1, Group 1,2: Cmax
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
PK_F_Part1, Group3
Part 1, Group 3: F
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start13 May 2022
- Primary completion13 Feb 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathly SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MitoImmune Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, MD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389696
- Sponsor's protocol ID
- MIT001-FD-SC01
- Status last verified
- Aug 2023
- First submitted
- 10 May 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of MIT-001 After Subcutaneous and Intravenous Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05389696
- Acronym / sponsor ID
- MIT001-FD-SC01
- Conditions
- Heathly Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MitoImmune TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part1. Group1. MIT-001 SC 10mg | Experimental | Drug: Single subcutaneous administration and Blood collectionSingle subcutaneous administration of 10mg MIT-001 or placebo |
| Part1. Group2. MIT-001 SC 20mg | Experimental | Drug: Single subcutaneous administration and Blood collectionSingle subcutaneous administration of 20mg MIT-001 or placebo |
| Part1. Group3. MIT-001 SC 40mg and IV 40mg | Experimental | Drug: Single subcutaneous administration and then IV injection.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 | Drug: MIT-001 20mg and 40mg_Multiple administrationMultiple subcutaneous administration of 20mg MIT-001/day or placebo for 7days |
| Part2. Group2: MIT-001 SC 40mg | Experimental | Drug: MIT-001 20mg and 40mg_Multiple administrationMultiple subcutaneous administration of 40mg MIT-001/day or placebo for 7days |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single subcutaneous administration and Blood collectionAlso: MIT-001 10mg and 20mgSingle subcutaneous administration and Blood collection | Drug | Part1. Group1. MIT-001 SC 10mg, Part1. Group2. MIT-001 SC 20mg |
| Single subcutaneous administration and then IV injection.Also: MIT-001 40mgSingle subcutaneous administration and then single intravenous administration after 2 weeks. In addition Blood collection is conducted as scheduled. | Drug | Part1. Group3. MIT-001 SC 40mg and IV 40mg |
| MIT-001 20mg and 40mg_Multiple administrationAlso: MIT-001 20mg and 40mgMultiple subcutaneous administration for 7 days and then blood collection | Drug | Part2. Group1: MIT-001 SC 20mg, Part2. Group2: MIT-001 SC 40mg |
Primary outcome
PK_Cmax_Part1 Group 1&2
Time frame: Part1. Group 1&2: Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1,2: Cmax
PK_Cmax_Part1 Group 3
Time frame: 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.
Part 1, Group 3: Cmax
PK_AUClast_Part1 Group 1&2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part1, Group 1\&2: AUClast
PK_AUClast_Part1 Group 3
Time frame: 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.
Part 1, Group 3: AUClast
PK_AUCinf_Part 1, Group 1&2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1\&2: AUCinf
PK_AUCinf_Part 1, Group 3
Time frame: 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.
Part 1, Group 3: AUCinf
PK_Tmax_Part 1, Group 1&2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1\&2: Tmax
PK_Tmax_Part 1, Group 3
Time frame: 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.
Part 1, Group 3: Tmax
PK_t1/2_Part 1, Group 1&2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1\&2: t1/2
PK_t1/2_Part 1, Group 3
Time frame: 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.
Part 1, Group 3: t1/2
PK_Vd/F_Part 1, Group 1&2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1\&2: Vd/F
PK_Vd/F_Part 1, Group 3
Time frame: 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.
Part 1, Group 3: Vd/F
PK_CL/F_Part 1, Group 1,2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1,2: CL/F
PK_CL/F_Part 1, Group 3
Time frame: 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.
Part 1, Group 3: CL/F
PK_MRT_Part 1, Group 1&2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1,2: MRT
PK_MRT_Part 1, Group 3
Time frame: 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.
Part 1, Group 3: MRT
PK_F_Part1, Group1,2
Time frame: Part1. Group 1&2_Before SC administration(Day0, 0hour) to 144hour after administration 16 points.
Part 1, Group 1,2: F
PK_F_Part1, Group3
Time frame: 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.
Part 1, Group 3: F
PK_Part2_Cmax
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Cmax
PK_Part2_Cmin
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
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
PK_Part2_Cavg
Time frame: Par2_Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Cavg
PK_Part2_AUCtau
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: AUCtau
PK_Part2_Tmax
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Tmax
PK_Part2_t1/2
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: t1/2
PK_Part2_Vd/F
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Vd/F
PK_Part2_CL/F
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: CL/F
PK_Part2_Cmax,ss
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Cmax,ss
PK_Part2_Cmin,ss
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Cmin,ss
PK_Part2_Cavg,ss
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Cavg,ss
PK_Part2_AUCtau,ss
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: AUCtau,ss
PK_Part2_Tmax,ss
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: Tmax,ss
PK_Part2_t1/2,ss
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: _t1/2,ss
PK_Part2_Vdss/F
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: _Vdss/F
PK_Part2_CLss/F
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: _VCLss/F
PK_Part2_PTF
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: _PTF
PK_Part2_Rac
Time frame: Part2: Before SC administration(Day0, 0hour) to 24hour 13points, Day5 0hour, Day6 0hour and then Day7 0hour to 216hour after SC administration 17points
Part 2: _Rac
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Heathly Subjects
Recruiting
Assessing the Effectiveness of Heat Adaptation Digital Messages From Primary Care Providers to Their Patients on the Change in Behaviour for Heatwave-related Preparedness
Heathly Subjects, Primary Health Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SeungHwan Lee, MD principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single subcutaneous administration and Blood collection, Single subcutaneous administration and then IV injection. and MIT-001 20mg and 40mg_Multiple administration in people with Heathly Subjects, run by MitoImmune Therapeutics at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK_Cmax_Part1 Group 1&2 (time frame: Part1. Group 1&2: Before SC administration(Day0, 0hour) to 144hour after administration 16 points.). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.