Completed
PHASE1
INTERVENTIONAL
NCT04555850
A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin Ξ²4οΌNL005οΌor placebo 0.5, 2.0,5.0ΞΌg/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.
Detailed Description
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 0.5ΞΌg/kg 2.0 ΞΌg/kg and 5.0 ΞΌg/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.
Interventions
Name:
Recombinant Human Thymosin Ξ²4
Type:
DRUG
Description:
Healthy subjects , were given a dose of rh-TΞ²4 for ten consecutive days.
Name:
Placebo
Type:
OTHER
Description:
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 .
Primary Outcomes
Measure:
Maximum Tolerated Dose (MTD) .
TimeFrame:
Day-7γ-1γ1γ2γ3γ4γ5γ6γ7γ8γ9γ10γ14γ28.
Description:
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).
Measure:
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
TimeFrame:
Day-7γ-1γ1γ2γ3γ4γ5γ6γ7γ8γ9γ10γ14γ28.
Description:
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.
Measure:
The Cmax of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The Tmax of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The MRT of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The AUClast of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The AUC0-inf of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The t1/2 of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The VZ of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The CL of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ2γ3γ4γ5γ6γ7γ8γ9γ10.
Description:
Approximately 5mL of venous blood was collected at allotted time for the pharmacokinetic study of rh-TΞ²4 in healthy subjects for the prescribed time.The pharmacokinetic parameters included Cmax , tmax ,MRT ,AUClast ,AUC0-inf,t1/2 ,VZ , CL.
Measure:
The potential immunological reaction (antibody formation) of multiple administration of rh-TΞ²4.
TimeFrame:
Day 1γ14γ28.
Description:
Approximately 5mL venous blood was collected from subjects before, 14 days after, and 28 days after administration for ADA study of rh-TΞ²4 in healthy subjects.After the 28th-day follow-up period, subjects who confirm that ADA results are positive should be reexamined every 30 days (Β±3 days) until the results turn negative or the titer level is stable for two consecutive times.
Trial Information
NCT ID
NCT04555850
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Beijing Northland Biotech. Co., Ltd.
Last Updated
December 15, 2025