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The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.
This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of SAL0140 tablets in healthy Chinese adult participants. Part B is a randomized, open-label, single-dose, two-period, two-sequence, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of SAL0140 tablets in healthy Chinese adult participants. Part C is a randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of SAL0140 tablets in healthy Chinese adult participants.
Part A will be conducted first, and Parts B and C will be initiated when appropriate based on the preliminary data obtained during the study. Each participant can only participate in one dose group in any part of the study after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Doses (SAD, Part A) | Experimental | In this part, 5 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 6:2 ratio to receive either SAL0140 or placebo. |
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| Experimental: Foode Effect (FE, Part B) | Experimental | 12 participants and single dose food effect cohort. This part is open-label, two sequence, two-period, crossover design. Participants will be randomly assigned to 1 of the 2 crossover sequence |
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| Experimental: Single Ascending Doses (MAD, Part C) | Experimental | In this part, 3 ascending dose cohorts (10 participants per cohort) will be studied. Within each cohort, participants will be randomized in an 8:2 ratio to receive either SAL0140 or placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL0140 | Drug | In this part, SAL0140 tablets will be administered as a single or multiple oral dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| The rate of Adverse events | The rate of Adverse events occur during the whole study | from Day 1 to Day8 or Day23 or Day28 |
| The rate of normality or abnormality of electrocardiogram | The rate of normality or abnormality of electrocardiogram during the whole study | from Day 1 to Day8 or Day23 or Day28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chongyuan Xu, Ph.D. | Contact | 13926186470 | nflcyljd@smu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chongyuan Xu, Ph.D | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| SAL0140 placebo | Drug | In this part, SAL0140 placebo tablets will be administered as a single or multiple oral dose. |
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