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| Name | Class |
|---|---|
| Peking University Care Luzhong Hospital | OTHER |
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This study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level S-2 | Experimental |
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| Dose level S-1 | Experimental |
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| Dose level S1 | Experimental |
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| Dose level S2 | Experimental |
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| Dose level S3 | Experimental |
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| Dose level S4 | Experimental |
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| Dose level S5 | Experimental |
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| Dose level S6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 0.03 mg/kg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of BT-114143 | The number of Treatment-Emergent Adverse Events (TEAEs) with a severity of Grade 2 or higher in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | For single administration, the follow-up will last until Day 15 after dosing; for multiple administrations, the follow-up will last until Day 21 after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Concentration | 15 days after administration |
| AUC | Area Under the Concentration-Time Curve | 15 days after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKU Care Luzhong Hospital | Zibo | Shandong | 255499 | China |
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| Dose level S7 | Experimental |
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| Dose level S8 | Experimental |
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| Dose level S9 | Experimental |
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| control group | Placebo Comparator |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 0.07 mg/kg. |
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| BT-114143 | Drug | 3 subjects will receive a single dose of BT-114143 injection at 0.15 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 0.3 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 0.6 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 1.2 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 2.4 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 4.8 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 8.4 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 12.6 mg/kg. |
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| BT-114143 | Drug | 6 subjects will receive a single dose of BT-114143 injection at 15 mg/kg. |
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| 0.9% Sodium Chloride Injection as Placebo | Drug | Except that the S1 dose group was a pilot study group with 1 subject matched to receive a placebo, all other dose groups were each matched with 2 subjects who received placebo treatment as controls. |
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| t1/2 | Half-Life | 15 days after administration |
| CL | Clearance | 15 days after administration |
| Vz | Volume of Distribution at Steady State | 15 days after administration |
| Changes in Plasminogen Activity Results from Baseline | Blood samples will be collected to determine the changes in plasminogen activation over time. | 72 hours after administration |
| Changes in Thromboelastography (TEG) Parameters | Blood samples will be collect at each timepoints and TEG parameter (including R, K, Angle, MA, LY30, and CI values) will be measured to determine coagulation function of each subject. | 72 hours after administration |
| Prothrombin Time(PT) | the trend of change in PT from baseline | 15 days after administration |
| Activated Partial Thromboplastin Time(APTT) | The change in Activated Partial Thromboplastin Time (APTT) from baseline | 15 days after administration |
| International Normalized Ratio(INR) | The change in INR (International Normalized Ratio) from baseline | 15 days after administration |
| Fibrinogen(FIB) | The change in FIB (Fibrinogen) from baseline | 15 days after administration |
| Thrombin Time(TT) | The change in TT (Thrombin Time) from baseline | 15 days after administration |
| D-Dimer | The change in D-Dimer (D-Dimer) from baseline | 15 days after administration |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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