A Phase 1, Repeat Dose Study to Evaluate the Safety, Tolerability, Biological Activity, and Pharmacokinetics of ND-L02-s0201 Injection in Japanese Subjects with Advanced Hepatic Fibrosis (METAVIR F3-4)

ITTO DENKO CORPORATIO0 个研究点目标入组 9 人开始时间: 2015年7月6日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
发起方
入组人数: 9

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 <= 75age old（—）
性别: All

入选标准

•1.The patient has a diagnosis of METAVIR F3-4 hepatic fibrosis at the pre-dose biopsy within 6 weeks before the first treatment or determined by liver biopsy done within 12 months before the screening visit (Cohort 1).
•2.The patient has adequate and stable synthetic hepatic function.
•3.The patient has adequate and stable hepatic function.
•4.The patient has platelet count > 75,000/mm3, hemoglobin > 10 g/dL, and white blood cell count (WBC) > 3000/uL.
•5.The patient has no signs of decompensated liver disease (ascites, hepatic encephalopathy, or variceal bleeding).
•6.The patient has no clinically significant abnormalities on 12-lead electrocardiogram (ECG).
•7.The patient has no other intercurrent medical conditions or infections considered clinically significant by the Investigator and the Sub-Investigator.
•8.The patient's clinical laboratory assessments are within the laboratory limits of normal values or not considered clinically significant by the Investigator and the Sub-Investigator.
•9.The patient's vitamin A levels at the screening visit must be less than or equal to the ULN (95 ug/dL or 3.32 umol/L).
•10.Any male subject,if sexually active, agrees to use barrier contraceptive techniques as defined in the protocol. If female, the patient must be non-lactating and of non-childbearing potential as defined in the protocol.
•11.Subjects who are active substance abusers may be enrolled at the discretion of the Investigator and the Sub-Investigator.
•The patient is willing and able to provide written informed consent and comply with the study procedures and visit schedule, including follow-up visits.

排除标准

•1.The patient has any disease or condition which, in the opinion of the Investigator and the Sub-Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND-L02-s0201Injection , or would place the patient at increased risk.
•2.The patient is on ongoing anti-virus therapy for HCV/HBV, or received anti-virus therapy for HCV/HBV within 12 weeks prior to administration of study drug.
•3.The patient is on interferon therapy for any disease, or received interferon therapy for any disease within 12 weeks prior to administration of study drug.
•4.The patients who started treatment of the primary disease or changed the dose of it within 12 weeks prior to administration of study drug.
•5.The patient has a history of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma.
•6.The patient has alpha-fetoprotein (AFP) > 50 ng/mL or signs of abnormality or hepatocellular carcinoma on ultrasound survey of the liver which are considered to be problematic for implementation of the study.
•7.The patient participated in a concurrent interventional study (including other clinical study for an investigational drug) with the last intervention occurring within 12 weeks prior to administration of study drug.
•8.The patient took vitamin A or vitamin D products (except for topical products) or supplements, or multi-vitamins that contain vitamin A or vitamin D between the screening visit and administration of study drug.
•9.The patient has a history, within the last 2 years, of alcohol abuse, significant mental illness, or physical dependence on any opioid.
•10.The patient has, in the opinion of the Investigator and the Sub-Investigator, veins unsuitable for repeated venipuncture or IV infusion (eg, veins that are difficult to locate, access, or puncture; veins with a tendency to have extravascular leak of injection solution).
•11.The patient has received recent treatment with alternative therapies, which, in the opinion of the Investigator and the Sub-Investigator, could potentially confound clinical or laboratory assessments.
•12.The patient who lost more than 400 mL of blood within 12 weeks prior for male or within 16 weeks prior for female, or the patient who lost more than 200 mL of blood within 4 weeks prior, or the patient who donated the blood component within 2 weeks prior to administration of study drug.
•13.The patient has a body mass index (BMI) > 33 kg/m2.
•14.The patient has a history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness (AIDS).
•15.The patient has a history of malignancy within the last 5 years, with the exception of basal cell carcinoma.
•16.The patient has a history of hypersensitivity to H2-receptor antagonists.
•17.The patient who is an employee of the study site or his/her family member or has a dependency relationship with an employee of the study site who is involved in the implementation of this study (eg, husband/wife, parent, child, brother/sister) or might give consent under compulsion.
•18.There is any other reason that, in the opinion of the Investigator and the Sub-Investigator or Medical Monitor, makes the patient unsuitable for enrollment.

研究者

发起方

ITTO DENKO CORPORATIO

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