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This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
Part A: SAD and FES study
Part B: MAD study
- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of repeated oral doses of IN-114199 in healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I(Cohort I) IN-114199 2.5 mg or Placebo | Experimental | SAD |
|
| Part I(Cohort 2) IN-114199 5 mg or Placebo | Experimental | SAD and FES |
|
| Part I(Cohort 3) IN-114199 10 mg or Placebo | Experimental | SAD and FES |
|
| Part I(Cohort 4) IN-114199 20 mg or Placebo | Experimental | SAD and FES |
|
| Part I(Cohort 5) IN-114199 40 mg or Placebo | Experimental | SAD |
|
| Part II(Cohort I) IN-114199 2.5 mg or Placebo | Experimental | MAD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-114199 2.5mg or placebo | Drug | IN-114199 2.5mg or placebo (1 Tablet, QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship | Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15) |
| Vital Sign | Vital sign results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199 | Part I : Up to Day 3/ Part II: Up to Day 9 |
| Physical Examination | Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of IN-114199. | Part I : Up to Day 3/ Part II: Up to Day 9 |
| Body Weight in kilograms Measurement | The body weight in kilograms of Subjects will be monitored daily from the administration of IN-114199 until their discharge | Part I : Up to Day 3 / Part II: Up to Day 9 |
| 12-lead electrocardiogram (ECG) | QT/QTc interval will be recorded and analyzed automatically. | Part I SAD: Up to Day 3 / Part II: Up to Day 9 |
| Clinical Laboratory Test | Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199 | Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters (Urine and Plasma) | Cmax | Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9 |
| PK parameters (Urine and Plasma) | AUClast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Hee Jung, Ph.D | Contact | +82-2-6477-0164 | shee.jung@inno-n.com | |
| Eun Ji Kim | Contact | +82-2-6477-0290 | eunji.kim24@inno-n.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital, Clinical Trial Center | Seoul | South Korea |
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| Part II(Cohort 2) IN-114199 5 mg or Placebo | Experimental | MAD |
|
| Part II(Cohort 3) IN-114199 10 mg or Placebo | Experimental | MAD |
|
| Part II(Cohort 4) IN-114199 20 mg or Placebo | Experimental | MAD |
|
| IN-114199 10mg or placebo | Drug | IN-114199 10mg or placebo (1 Tablet, QD) |
|
| IN-114199 20mg or placebo | Drug | IN-114199 10mg or placebo (2 Tablets, QD) |
|
| IN-114199 40mg or placebo | Drug | IN-114199 10mg or placebo (4 Tablets, QD) |
|
| IN-114199 5mg or placebo | Drug | IN-114199 2.5mg or placebo (2 Tablets, QD) |
|
| Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9 |
| PD parameters (plasma C4 level) | AUEClast | Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9 |
| PD parameters (plasma LDL/HDL level) | AUEClast | Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8 |