NCT04555850

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 29, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 8, 2020

Last Update Submit

September 27, 2020

Conditions

Healthy

Keywords

Recombinant human thymosin β4

Outcome Measures

Primary Outcomes (11)

  • 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.

    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.

Study Arms (4)

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.

Drug: Recombinant Human Thymosin β4

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.

Drug: Recombinant Human Thymosin β4

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.

Drug: Recombinant Human Thymosin β4

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.

Other: Placebo

Interventions

Recombinant Human Thymosin β4DRUG

Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.

Also known as: rh-β4
Recombinant Human Thymosin β4 0.5ug/kgRecombinant Human Thymosin β4 2.0ug/kgRecombinant Human Thymosin β4 5.0ug/kg
PlaceboOTHER

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 .

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese healthy volunteers（male or female）.
  • Between 18 and 50 years of age.
  • Female subjects should weigh no less than 45 kg and male subjects should weigh no less than 50 kg.BMI between 19 and 28 kg/m2.
  • Good health condition, no history of unintentional, liver, kidney, digestive tract, immune system, nervous system, mental and metabolic abnormality, no family history of tumor.
  • Ability to communicate normally with medical staff, understand research requirements and comply with hospital regulations.
  • Voluntarily sign informed consent.

You may not qualify if:

  • Physical examination vital signs electrocardiogram and laboratory examination are not done or any result is judged to be clinically significant abnormal (judged by clinician).
  • ADA tests positive.
  • Smoking more than 5 cigarettes a day for the previous 3 months, or no guarantee to stop smoking during the trial.
  • Previous history of substance abuse or drug screening test positive.
  • Any other drug was used within two weeks before the trial.
  • There is a significant clinical history of allergy, especially for drugs, protein preparations and biological products, especially for rh-tβ4 or any of its ingredients.
  • Blood donation or blood loss was equal to or greater than 400 mL within three months prior to the trial.
  • Female subjects who are pregnant or breast-feeding, or who are likely to become pregnant without using an acceptable method of contraception, or who are positive for a pregnancy test, and male subjects who are not using effective contraception or whose partner has a family planning plan within six months of the end of the trial.
  • Unable to tolerate venous blood collection.
  • There is no guarantee that smoking and taking grapefruit juice or any alcoholic and xanthine food and beverage (including chocolate, tea, coffee, cola, etc.) from 48 hours before administration to the last blood sample collection.
  • The investigator judges that the subject is unable to complete the study or otherwise considers that the subject's participation in the study may cause other injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Shijitan Hospital

Beijing, China

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Dose Escalation for 3 Cohorts.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

September 21, 2020

Study Start

July 30, 2018

Primary Completion

February 18, 2019

Study Completion

July 26, 2019

Last Updated

September 29, 2020

Record last verified: 2020-05

Locations

CN(1)