Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation, and multiple-dose study to evaluate safety, tolerability, PK and PD of MY008211A Tablets in healthy subjects.
MY008211A Tablets, low/moderate/high dose orally, continually 7 days
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1:Dose1 | Experimental | 8 subjects received Dose 1 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days |
|
| Group 2:Dose2 | Experimental | 8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days |
|
| Group 3:Dose3 | Experimental | 8 subjects received Dose 2 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days |
|
| Group 4: Dose4 | Experimental | 8 subjects received Dose 4 of MY008211A Tablets, and 2 subjects received placebo, continually 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MY008211A tablets | Drug | MY008211A tablets, low/moderate/high dose orally, for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events to assess safety and tolerability | such as laboratory abnormalities | up to 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) Of MY008211A tablets | Maximum Plasma Concentration (Cmax) | up to 10 days |
| Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A | Maximum Plasma Concentration (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum LDH levels from baseline | serum LDH levels | up to 10 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MY008211A tablets matched placebo | Drug | MY008211A tablets matched placebo, low/moderate/high dose orally, for 7 days |
|
|
| up to 10 days |
| Area Under The Concentration Versus Time Curve (AUC) Of MY008211A | Area Under The Concentration Versus Time Curve (AUC) | up to 10 days |
| Half Life (t1/2) Of MY008211A | Half Life (t1/2) | up to 10 days |
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |