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This is a single-center, randomized,double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) of MT1011 injection in healthy adult subjects. Includes 5 dose cohorts, with 40 subjects planned for enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT1011 | Experimental | Interventional: The SAD study involves single administration of MT1011 |
|
| Placebo | Placebo Comparator | Placebo: The SAD study involves single administration of Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1011 | Drug | MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs). | The occurrence of all adverse events (AEs), serious adverse events (SAEs) | up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of MT1011 | Cmax - Maximum plasma concentration | Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose. |
| Tmax of MT1011 | Tmax - Time to reach Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Hua Hao, Ph.D. in Medicine | Contact | 010-63926883 | xiaohualuck@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100038 | China |
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| Placebo | Drug | This intervention contains no active ingredients |
|
| Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose. |
| T1/2 of MT1011 | t1/2 - Elimination half-life | Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose. |
| AUC0-tau of MT1011 | AUC0-tau - Area under the plasma concentration-time curve during one dosing interval | Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose. |
| AUC0-t of MT1011 | AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration | Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose. |
| Whole blood clotting time | Whole blood clotting time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. |
| Activated partial thromboplastin time | Activated partial thromboplastin time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. |
| Prothrombin time | Prothrombin time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. |
| fibrinogen | fibrinogen | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. |
| International normalized ratios | International normalized ratios | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. |
| Thrombin time | Thrombin time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. |
| Factor Xa activity | Factor Xa activity | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. |