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To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity.
This study was divided into two parts: Part A and Part B. Part A was single-center, randomized, double-blind, and placebo control, single-dose escalation study (SAD) was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after a single dose. Furthermore, food effect would be preliminarily evaluated the influence of the pharmacokinetic characteristics of SAL0133 tablets in Part A. Part B was a single-center, randomized, double-blind, placebo controlled, multiple-dose escalation study was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD 50mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fasting condition |
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| SAD 150mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fasting condition |
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| SAD 300mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fasting condition |
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| SAD 150mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fed condition |
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| SAD 300mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily under fed condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL0133 | Drug | once daily single dose or seven days multiple dose of SAL0133 tables |
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| Measure | Description | Time Frame |
|---|---|---|
| The rate of AE | The rate of AE occurred in the whole study | from Day 1 to Day 5 or Day 10 |
| The rate of SAE | The rate of SAE occurred in the whole study | from Day 1 to Day 5 or Day 10 |
| blood pressure | the change (mmHg) of blood pressure including SBP and DBP in the whole study | from Day 1 to Day 5 or Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongying Yang, M.D | Shenzhen People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Shenzhen | Guangdong | China |
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| SAD 600mg Fed |
| Experimental |
6 subjects received active drug and 2 subjects received placebo once daily under fed condition |
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| MAD 150mg Fasting | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition |
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| MAD 150mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition |
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| MAD 300mg Fed | Experimental | 6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition |
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| SAL0133 placebo | Drug | once daily single dose or seven days multiple dose of SAL0133 placebo |
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