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This is a phase Ⅰ,single-center, randomized, double-blinded, placebo-controlled, single ascending dose trial of SY-009 in healthy subjects.
This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic / pharmacodynamic study of a single oral SY-009 capsule for Chinese healthy subjects. Plan to screening no more than 64 healthy subjects , dividing them into 7 dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SY-009 dose 1 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. |
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| SY-009 dose 2 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. |
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| SY-009 dose 3 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. |
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| SY-009 dose 4 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. |
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| SY-009 dose 5 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. |
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| SY-009 dose 6 | Experimental | A single dose of SY-009 (0.5-40mg) taken orally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-009 | Drug | The study will be initiated in healthy subjects at a 0.5mg dose that is the maximum recommended starting dose(MRSD) . Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 2,5, 10, 20, 40mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review. |
| Measure | Description | Time Frame |
|---|---|---|
| The Safety and tolerance of SY-009,Collecting Number of subjects with adverse events as assessed by CTCAE V5.0 | Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal Laboratory Values, abnormal vital signs, Abnormal physical examination, Abnormal ECG data. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| area under curve (AUC) of SY-009 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-009 following oral administration of single ascending dose |
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Inclusion Criteria:
1、healthy subject:determined by medical history, physical examination, Imaging examination, abdominal B-mode ultrasonography (include liver, gallbladder, pancreas, spleen and kidney), electrocardiogram and laboratory tests. Test results within the normal range for the population or investigator site, or with abnormalities deemed clinically insignificant by the investigator; 2、Gender: Male and female, gender balance; 3、Age: 18-65 years old (including the boundary values); 4、Weight ≥50kg and 19.0kg/m2≤BMI≤28.0kg/m2 [BMI=body weight(kg)/height 2 (m2); 5、fasting plasm glucose (FPG): 3.9-6.1mmol/L (excluding the boundary valuses); 6、2h postprandial plasma giucose(2hPPG)<7.8mmol/L; 7、glycosylated hemoglobin (HbA1c) <5.7%;
8、have venous access sufficient to allow blood sampling as per the protocol;
9、Subjects must have informed consent before the study and sign a written informed consent form voluntarily;
10、Subjects can communicate well with investigator and complete the study according to the protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingtong Li, Doctor | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100000 | 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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Parallel ,Placebo control
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| SY-009 matching placebo | Placebo Comparator | from 2-40mg |
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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-009 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-009 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-009 | FPG AUC | 3 Days |
| insulin secretion following single dose of SY-009 | insulin changes | 3 Days |
| C-peptide secretion following single dose of SY-009 | C-peptide change | 3 Days |