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The study is a Phase 2a, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the pharmacodynamics (PD), safety and pharmacokinetics (PK) of multiple doses of SRSD107 in participants with coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with aspirin as background concomitant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRSD107 dose level 1 | Experimental | Administered S.C. |
|
| SRSD107 dose level 2 | Experimental | Administered S.C. |
|
| SRSD107 dose level 3 | Experimental | Administered S.C. |
|
| SRSD107 dose level 4 | Experimental | Administered S.C. |
|
| Placebo | Placebo Comparator | Administered S.C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRSD107 | Drug | Administered S.C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in time-averaged FXI antigen | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in FXI antigen, FXI activity and aPTT | 72 weeks | |
| Maximal concentration of SRSD107 | 72 weeks | |
| Area under the concentration-time curve from time 0 to infinity of SRSD107 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.9 % sodium chloride | Drug | Administered S.C. |
|
| 72 weeks |
| Time to the maximal concentration of SRSD107 | 72 weeks |
| Incidence of adverse events | 72 weeks |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
| D017670 |
| Sodium Compounds |