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This is a phase â… ï¼Œsingle-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-008 in healthy subjects.
This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-008 capsule for Chinese healthy subjects. Plan to screening total of 54 healthy subjects , dividing them into 6 dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SY-008 dose 1 | Experimental | A single dose of SY-008 (2~30mg) taken orally. |
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| SY-008 dose 2 | Experimental | A single dose of SY-008 (2~30mg) taken orally. |
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| SY-008 dose 3 | Experimental | A single dose of SY-008 (2~30mg) taken orally. |
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| SY-008 dose 4 | Experimental | A single dose of SY-008 (2~30mg) taken orally. |
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| SY-008 dose 5 | Experimental | A single dose of SY-008 (2~30mg) taken orally. |
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| SY-008 matching placebo | Placebo Comparator | from 6mg to 30mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-008 | Drug | The study will be initiated in healthy subjects at a 2-mg dose that is expected to have minimal pharmacologic effect. Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 6, 12, 18, 24, 30mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| area under curve (AUC) of SY-008 following oral administration of single ascending dose | to measure the study drug concentration in blood samples to be collected after drug administration. | 3 days |
| Cmax of SY-008 following oral administration of single ascending dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feng Shao, Doctor | The Frist Affiliated Hospital Of Nanjing Madical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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to measure the study drug concentration in blood samples to be collected after drug administration. |
| 3 days |
| T1/2 of SY-008 following oral administration of single ascending dose | to measure the study drug concentration in blood samples to be collected after drug administration. | 3 days |
| CL/F (Clearance rectified) of SY-008 following oral administration of single ascending dose | to measure the study drug concentration in blood samples to be collected after drug administration. | 3 days |
| glucose levels following single dose of SY-008 | FPG AUC | 24 hours |
| insulin secretion following single dose of SY-008 | insulin changes | 3 days |
| C-peptide secretion following single dose of SY-008 | C-peptide change | 6 hours |