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The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants. Seven dose groups (A1 to A7) were preset. A total of 48 healthy subjects were planned to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SK-08 | Experimental | Seven sequential dose groups(A1-A7) will be evaluated: 5 mg, 7.5mg,12.5 mg, 20 mg, 30 mg, 45 mg, and 60 mg. SK-08 were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups. |
|
| Placebo | Placebo Comparator | Seven sequential dose groups(A1-A7) will be evaluated: 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg. Placebo were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SK-08 | Drug | Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | The occurrence of AE during the experiment | up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| PK Evaluation(Cmax) | Pharmacokinetic characteristics after administration (Cmax) | within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing |
| PK Evaluation(Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIAN LIU, Master | Contact | 13958054006 | lindaliu87@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo |
| Drug |
Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once. |
|
Pharmacokinetic characteristics after administration |
| within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing |
| PK Evaluation( AUC0-T) | Pharmacokinetic characteristics after administration (AUC0-T) | within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing |
| PK Evaluation ( AUC0-∞) | Pharmacokinetic characteristics after administration ( AUC0-∞) | within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing |
| PD Evaluation(Heart rate) | Heart rate | within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing |
| PD Evaluation(blood pressure) | blood pressure | within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing |
| PD Evaluation(changes in cGMP concentration levels) | changes in cGMP concentration levels | within 1.00 hour pre-dosing and 0.50 hour, 1hour,1.5hour,2hour,2.5hour,3hour,4hour,5hour,6hour,8hour,12hour post-dosing |
| QT interval analysis indicators(QTcF) | QTcF | With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing |
| QT interval analysis indicators(ΔQTcF) | ΔQTcF | With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |