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The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KL1333 25mg | Experimental | Group 1 |
|
| KL1333 50mg | Experimental | Group 2 |
|
| KL1333 100mg | Experimental | Group 3 |
|
| KL1333 200mg | Experimental | Group 4 |
|
| KL1333 400mg | Experimental | Group 5 |
|
| KL1333 600mg | Experimental | Group 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL1333 25 mg | Drug | oral administration, single dose, 25 mg 1 tab |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reported adverse events | from day 1 to day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of KL1333 | from day 1 to day 15 | |
| Area Under the Curve (AUC) of KL1333 | from day 1 to day 15 | |
| Half-life (T1/2) of KL1333 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD., MBA | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 110744 | South Korea |
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| KL1333 800mg |
| Experimental |
Group 7 |
|
| KL1333 50 mg |
| Drug |
oral administration, single dose, 25 mg 2 tabs |
|
| KL1333 100 mg | Drug | oral administration, single dose, 100 mg 1 tab |
|
| KL1333 200 mg | Drug | oral administration, single dose, 100 mg 2 tabs |
|
| KL1333 400 mg | Drug | oral administration, single dose, 100 mg 4 tabs |
|
| KL1333 600 mg | Drug | oral administration, single dose, 100 mg 6 tabs |
|
| KL1333 800 mg | Drug | oral administration, single dose, 100 mg 8 tabs |
|
| Placebo | Drug | oral administration, placebo |
|
| from day 1 to day 15 |
| ID | Term |
|---|---|
| D017241 | MELAS Syndrome |
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D017237 | Mitochondrial Encephalomyopathies |
| D017240 | Mitochondrial Myopathies |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D009468 | Neuromuscular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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