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This is a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153.
Healthy young and elderly adult volunteers who meet the criteria, will be treated single and multiple ascending dose of BEY2153 or placebo orally. Food effect evaluation study will be conducted with single ascending dose. After the single ascending dose study, independent external experts will review blinded data and multiple ascending dose study will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD (#6 Cohort) | Experimental | Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once. |
|
| SAD (#1 Cohort) - Food effect evaluation | Experimental | Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo for two periods at 7 days interval, with both fasting and after high fat meal. |
|
| MAD (#4 Cohort) | Experimental | Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEY2153 | Drug | Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Day 1 to Day 9 | |
| Area Under the Curve (AUC) | Day 1 to Day 9 | |
| Apparent terminal elimination half-life (t1/2) | Day 1 to Day 9 | |
| Apparent clearance (CL/F) | Day 1 to Day 9 | |
| Apparent volume of distribution (Vz/F) | Day 1 to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 48 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 48 days | |
| Incidence of clinically significant changes in vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Up to 18 days |
| Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters | Up to 18 days |
| Incidence of clinically significant changes in clinical laboratory results | Up to 18 days |
| Incidence of clinically significant changes in physical examination | Up to 18 days |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |