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This was a single-center, single-dose, open-label clinical study. 12 subjects were randomly assigned in a 1:1 ratio to one of the following dosing sequences (sequence 1: AB; Sequence 2: BA). Each dosing sequence consisted of two cycles, one dose per cycle, with a 5-day washout period between doses.
A: A single dose of MY008211A tablets was administered in the fasting state (fasting for at least 10 h with water as needed).
B: A single dose of MY008211A tablets was administered after a standard high-fat, high-calorie fed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 : AB | Experimental | 6 subjects were given a single dose of MY008211A tablets in the fasting state and, after a 5-day washout period, a single dose of MY008211A tablet was administered after taking a standard high-fat and high-calorie fed. |
|
| Sequence 1 : BA | Experimental | 6 subjects were given a single dose of MY008211A tablet after taking a standard high-fat and high-calorie fed and, after a 5-day washout period, a single dose of MY008211A tablet in the fasting state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MY008211A tablets | Drug | A single dose of MY008211A tablet was administered after fasting and high-fat, high-calorie feeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Maximum Plasma Concentration (Cmax) Of MY008211A tablets | up to 72 hours postdose |
| The Maximum Plasma Concentration (Tmax) | Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A | up to 72 hours postdose |
| Area Under The Concentration Versus Time Curve (AUC) | Area Under The Concentration Versus Time Curve (AUC) Of MY008211A | up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events to assess safety and tolerability | such as laboratory abnormalities | up to 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei feng, Ph.D | Wuhan Createrna Science and Technology Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Changsha | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |