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The trial is the first human trial. The safety, tolerability, PK and PD of MY008211A Tablets will be evaluated in healthy subjects.
This is a single ascending dose, randomized, double-blind study,with 5 dose groups preset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dose1 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 1. |
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| Group 2: Dose2 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 1. |
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| Group 3: Dose3 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 1. |
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| Group 4: Dose4 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 1. |
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| Group 5: Dose5 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 1. |
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| Group 6: Dose6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MY008211A tablets | Drug | Single oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events to assess safety and tolerability | such as laboratory abnormalities | up to 21days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) Of MY008211A tablets | Maximum Plasma Concentration (Cmax) | up to 72 hours postdose |
| Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A | The Maximum Plasma Concentration (Tmax) |
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Inclusion Criteria:
1.18≤ age ≤ 45, male or female;
2.Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m2 (inclusive);
3.Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
4.The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
Exclusion Criteria:
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| 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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Participants randomized to receive MY008211A tablets or placebo on Day 1. |
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| Group 7: Dose7 | Experimental | Participants randomized to receive MY008211A tablets or placebo on Day 1. |
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| Placebo | Drug | Single oral |
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| up to 72 hours postdose |
| Area Under The Concentration Versus Time Curve (AUC) Of MY008211A | Area Under The Concentration Versus Time Curve (AUC) | up to 72 hours postdose |
| Half Life (t1/2) Of MY008211A | Half Life (t1/2) | up to 72 hours postdose |
| Changes in serum C3 levels from baseline | serum C3 levels | up to 72 hours postdose |
| Changes in serum LDH levels from baseline | serum LDH levels | up to 72 hours postdose |
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |