A Randomized, Double-blind, Placebo-Controlled, Multiple Doses,Dose-escalation，Phase 1b Study of the Safety, Tolerability，Pharmacokinetics and the Potential Immunological Reaction of Recombinant Human Thymosin Beta4 in Chinese Healthy Volunteers

Beijing Northland Biotech. Co., Ltd.1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2018年7月30日最近更新: 2020年9月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Beijing Northland Biotech. Co., Ltd.
入组人数: 30
试验地点: 1
主要终点: Maximum Tolerated Dose (MTD) .

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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/m
•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.

排除标准

•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.
•Alcohol intake averaged more than 2 units per day (1 unit = 360mL beer,150mL wine or 45mL 40% alcohol liquor) or alcohol test positive in the first 3 months of inclusion.
•Participated in another trial or used this drug within 3 months before inclusion.
•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.

研究组 & 干预措施

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.

干预措施: Recombinant Human Thymosin β4 (Drug)

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.

干预措施: Recombinant Human Thymosin β4 (Drug)

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.

干预措施: Recombinant Human Thymosin β4 (Drug)

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.

干预措施: Placebo (Other)

结局指标

主要结局

Maximum Tolerated Dose (MTD) .

时间窗: Day-7、-1、1、2、3、4、5、6、7、8、9、10、14、28.

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).

The Cmax of multiple administration of rh-Tβ4.