Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on Day 1.
This study is a randomized,double-blind,placebo-controlled, investigation to evaluate the safety, tolerability, pharmacokinetics and the potential immunological reaction of single of NL005 administered intravenously to healthy volunteers.
In Phase 1A, Seven (7) cohorts of subjects (first two cohorts 2 subjects respectively, 10 subjects per cohort for next 5 cohorts) will administered one dose of NL005 or placebo in a 4:1 ratio. Dosing start at 0.05μg/kg and advance to 0.25, 0.5, 2, 5, 12.5, 25μg/kg.
NL005 or placebo administered as a single dose on Day 1. Safety parameters recorded on Study Days 1, 2, 5, 14, and 28. Evaluation of adverse events performed throughout the study. Pharmacokinetic samples obtained on Study Day 1. Blood samples collected for serum antibody determinations at Screening , Days 14 and 28.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Thymosin β4 Dose 1 group | Experimental | Two subjects in this group will receive NL005 for 0.05ug/kg respective in D1. |
|
| Dose 2 groupRecombinant Human Thymosin β4 | Experimental | Two subjects in this group will receive NL005 for 0.25ug/kg respective in D1. |
|
| Dose 3 groupRecombinant Human Thymosin β4 | Experimental | Eight subjects in this group will receive NL005 for 0.5ug/kg respective in D1. |
|
| Dose 4 groupRecombinant Human Thymosin β4 | Experimental | Eight subjects in this group will receive NL005 for 2ug/kg respective in D1. |
|
| Dose 5 groupRecombinant Human Thymosin β4 | Experimental | Eight subjects in this group will receive NL005 for 5ug/kg respective in D1. |
|
| Recombinant Human Thymosin β4 Dose 6 group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Thymosin β4 | Drug | Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1. |
|
| 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). | Day1 |
| 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. | Day1 |
| The Cmax of single ascending doses 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. |
| The Tmax of single ascending doses 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital | Beijing | China |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Dose Escalation for 7 Cohorts.
Not provided
Not provided
Not provided
| Experimental |
Eight subjects in this group will receive NL005 for 12.5ug/kg respective in D1. |
|
| Recombinant Human Thymosin β4 Dose 7 group | Experimental | Eight subjects in this group will receive NL005 for 25ug/kg respective in D1. |
|
| Placebo | Placebo Comparator | Two subjects in each dose group(0.5/2/5/12.5/25ug/kg)were given placebo respective in D1. A total of 10 subjects were given placebos. |
|
|
| Placebo | Other | Five cohorts, with 10 healthy subjects , were given a single intravenous dose of Placebo. Cohorts received ascending doses of either 0.5, 2,5,12.5 or 25 ug/kg in Day1. |
|
| The MRT of single ascending doses 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. |
| The AUClast of single ascending doses 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. |
| The AUC0-inf of single ascending doses 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. |
| The t1/2 of single ascending doses 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. |
| The VZ of single ascending doses 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. |
| The CL of single ascending doses 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. |
| The potential immunological reaction (antibody formation) of single ascending doses 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. |