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The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4(NL005)or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.
This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability pharmacokinetics and potential immune responses of multiple NL005 intravenous administration.
Three groups of 30 subjects will receive an NL005 or placebo dose of 0.5μg/kg 2.0 μg/kg and 5.0 μg/kg for 10 consecutive days at a ratio of 4:1.
While observing the safety of the subjects in each dose group, about 5mL of venous blood was collected for the ADA study in healthy subjects 14 days and 28 days after the first administration of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Thymosin β4 0.5ug/kg | Experimental | 10 subjects in this group will receive NL005 for 0.5ug/kg respective.Continuous administration for 10 days. |
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| Recombinant Human Thymosin β4 2.0ug/kg | Experimental | 10 subjects in this group will receive NL005 for 2.0ug/kg respective.Continuous administration for 10 days. |
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| Recombinant Human Thymosin β4 5.0ug/kg | Experimental | 10 subjects in this group will receive NL005 for 5.0ug/kg respective.Continuous administration for 10 days. |
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| Placebo | Other | Two subjects in each dose group (0.5/2/5ug/kg) were given placebo for 10 days.A total of six participants were given a placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Thymosin β4 | Drug | Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) . | Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. In this study, DLT was defined as liver, kidney, heart and mental nervous system toxicity of level 2 or above or blood system toxicity of level 3 or above and other systemic adverse events occurred within 14 days after drug administration, and the adverse events were judged to be related to the experimental drug use.If more than 3 (including 3) DLT cases are present in any dose group, the test should be terminated. The previous dose of this dose is considered the maximum tolerated dose (MTD). | Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. | Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. All adverse events were determined according to NCI CTCAE4.03.CTCAE4.03 was classified into grades 1 to 5, in which grade 1 was mild adverse event and grade 5 was death due to adverse event.According to NCI CTCAE4.03. | Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28. |
| The Cmax of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. | Day 1、2、3、4、5、6、7、8、9、10. |
| The Tmax of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital | Beijing | China |
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| Label | URL |
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| Related Info | View source |
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Dose Escalation for 3 Cohorts.
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| Placebo | Other | 3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg . |
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| Day 1、2、3、4、5、6、7、8、9、10. |
| The MRT of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. | Day 1、2、3、4、5、6、7、8、9、10. |
| The AUClast of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. | Day 1、2、3、4、5、6、7、8、9、10. |
| The AUC0-inf of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. | Day 1、2、3、4、5、6、7、8、9、10. |
| The t1/2 of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. | Day 1、2、3、4、5、6、7、8、9、10. |
| The VZ of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. | Day 1、2、3、4、5、6、7、8、9、10. |
| The CL of multiple administration of rh-Tβ4. | Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-Tβ4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL. | Day 1、2、3、4、5、6、7、8、9、10. |
| The potential immunological reaction (antibody formation) of multiple administration of rh-Tβ4. | Approximately 5mL venous blood was collected from subjects before, 14 days after, and 28 days after administration for ADA study of rh-Tβ4 in healthy subjects.After the 28th-day follow-up period, subjects who confirm that ADA results are positive should be reexamined every 30 days (±3 days) until the results turn negative or the titer level is stable for two consecutive times. | Day 1、14、28. |