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This is a single-dose/multiple-doses incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.
This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic study of a single-dose/multiple-doses incremental intravenous injection of SY-005(recombinant human annexin A5) in healthy subjects. Six sigle-dose group trials are planned: 0.75mg, 2.5mg, 5mg, 10mg, 15mg,and 20mg and three multiple-doses groups are planned: 5mg, 10mg and 20mg. Single-dose groups are planned to enroll 64 subjects and multiple-doses groups are planned to enroll 30 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SY-005 single-dose 0.75mg | Experimental | 4 subjects will be envolved in this group and be injected with 0.75mg of SY-005. |
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| SY-005 single-dose 2.5mg | Placebo Comparator | This group will be intiated in healthy subjects at a 2.5mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. |
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| SY-005 single-dose 5mg | Placebo Comparator | This group will be intiated in healthy subjects at a 5mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. |
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| SY-005 single-dose 10mg | Placebo Comparator | This group will be intiated in healthy subjects at a 10mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. |
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| SY-005 single-dose 15mg | Placebo Comparator | This group will be intiated in healthy subjects at a 15mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SY-005 | Drug | This single-dose group will be initiated in healthy subjects at a 0.75mg dose that is the maximum recommended starting dose(MRSD). Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are2.5mg, 5mg, 10mg, 15mg, 20mg successively. The dose of multiple-doses groups are depending on the results of single-dose groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events of SY-005 | Incidence of adverse events of SY-005, collecting number of subjects with adverse events as assessed by CTCAE V5.0. Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal laboratory values, abnormal vital signs, abnormal physical examination, abnormal ECG data. | Single-dose: 21 days/ Multiple-doses: 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) of SY-005 following injection of single dose/multiple-doses | To mearsure the study drug concentration in blood samples which collected after injection | Single-dose: 24 hours/ Multiple-doses: 8 days |
| Cmax of SY-005 following injection of single dose/multiple-doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 26, 2023 | |
| Reset | Feb 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2023 | Feb 14, 2024 |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| SY-005 single-dose 20mg | Placebo Comparator | This group will be intiated in healthy subjects at a 20mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. |
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| SY-005 multiple-doses 5mg | Placebo Comparator | This group will be intiated in healthy subjects at a 5mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days. |
|
| SY-005 multiple-doses 10mg | Placebo Comparator | This group will be intiated in healthy subjects at a 10mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days. |
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| SY-005 multiple-doses 20mg | Placebo Comparator | This group will be intiated in healthy subjects at a 20mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days. |
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To mearsure the study drug concentration in blood samples which collected after injection |
| Single-dose: 24 hours/ Multiple-doses: 8 days |
| Tmax of SY-005 following injection of single dose | To mearsure the study drug concentration in blood samples which collected after injection | Single-dose: 24 hours/ Multiple-doses: 8 days |
| T1/2 of SY-005 following injection of single dose | To mearsure the study drug concentration in blood samples which collected after injection | Single-dose: 24 hours/ Multiple-doses: 8 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |