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To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral dosing in the fed state in obese or overweight subjects.
dose block-randomized, double-blinded, placebo controlled, single or multiple ascending dose study. AEs, PE, Vital signs, ECGs and Clinical lab tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KD101 | Experimental |
| |
| KD101 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KD101 | Drug | 200mg, 400mg, 800mg, 1400mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters - Cmax | Cmax (Maximum concentration of drug in plasma) | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic parameters - PBMCs | PBMC (Peripheral blood mononuclear cell) | up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Lee, Professor | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| placebo | Drug | 200mg, 400mg, 800mg |
|
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |