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First in human study
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH4808 30mg | Experimental | 1.Single dose 2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 50mg | Experimental | 1.Single dose 2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 100mg | Experimental | 1.Single dose 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 200mg | Experimental | 1.Single dose 2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 400mg | Experimental | 1.Single dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 100mg(repeat doses) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH4808 30mg | Drug | YH4808 30mg (single dose) |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808 | Throughout the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical trials center, Seoul national university hospital | Seoul | 110-744 | South Korea |
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| Experimental |
1.Repeat doses 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 200mg(repeat doses) | Experimental | 1.Repeat doses 2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2) |
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| YH4808 400mg(repeat doses) | Experimental | 1.Repeat dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 600mg | Experimental | 1.Single dose 2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| YH4808 800mg | Experimental | 1.Single dose 2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
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| Placebo | Placebo Comparator |
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| Esomeprazole 40mg | Active Comparator |
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| YH4808 50mg | Drug | YH4808 50mg (single dose) |
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| YH4808 100mg | Drug | YH4808 100mg (single dose) |
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| YH4808 200mg | Drug | YH4808 200mg (single dose) |
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| YH4808 | Drug | YH4808 400mg (single dose) |
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| YH4808 100mg (repeat dose) | Drug | YH4808 100mg (repeat dose) |
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| YH4808 200mg (repeat dose) | Drug | YH4808 200mg (repeat dose) |
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| YH4808 600mg | Drug | YH4808 600mg |
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| YH4808 800mg (single dose) | Drug | YH4808 800mg (single dose) |
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| YH4808 400 mg (repeat doses) | Drug | YH4808 400 mg (repeat doses) |
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| Placebo | Drug | 10 volunteers will be administered matched placebo. |
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| Esomeprazole 40mg | Drug | 24 volunteers will be administered Esomeprazole 40mg |
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| ID | Term |
|---|---|
| C000625316 | YH4808 |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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