NCT04140123已完成1 期
A Multi-center, Randomized, Double-blind, Dose-increasing, Placebo-controlled，Multi-dose, 28-day Continuous Administration Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, Efficacy, and PK of ZSP1601 in Patients With Nonalcoholic Steatohepatitis
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年6月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo.
研究概览
简要总结
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are required to meet the following criteria in order to be included in the trial:
- •Signature signed informed consent before the trial, and fully understood the content, process and possible adverse reactions.
- •Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Subjects(including partners)have no gestation plans and must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- •Male and female subjects aged 18-65 (including 18 and 65).
- •B ultrasound confirmed fatty liver.
- •NASH diagnosis or NASH phenotypic diagnosis.
- •Liver fat ≥10% at baseline (MRI-PDFF)
排除标准
- •Eligible subjects must not meet any of the following exclusion criteria:
- •Excessive drinking for 3 consecutive months within 1 year before screening.
- •Allergic constitution.
- •Subjects who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
- •Subjects having a history of bariatric surgery or preparing for bariatric surgery recently.
- •Subjects having a history of liver transplantation or plans for liver transplantation
- •Any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers.
- •Liver biopsy indicates cirrhosis or previous clinical diagnosis of cirrhosis.
- •Type 1 diabetes mellitus.
- •Uncontrolled type 2 diabetes mellitus (HbA1c≥8.0%)。
- •Any clinically significant abnormality upon physical examination or in the clinical laboratory tests, history or presence of other causes of liver disease,but not limited to above disorders: hepatitis b or hepatitis c virus (HCV) infection and chronic alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson 's disease, alpha 1 - antitrypsin deficiency, liver, obvious abnormal liver function (ALT and AST acuity 5 x ULN or TBIL acuity 1.5 x ULN), etc.
- •Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
- •History of having any special food(including dragon fruit,mango,grapefruit,etc.),strenuous exercises,or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 2 weeks prior to screening.
- •Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
- •Presence of clinically significant abnormalities in ECG or QTcB>450ms in males,or QTcB>470ms in females.
- •HIV positive.
- •Clinically significant nephropathy or renal dysfunction, blood creatinine >1.5×ULN, eGFR< 60 mL/min/1.73m2 [calculation formula: Ccr:(140-age)× weight (kg) /0.818×Scr(mumol /L), female ×0.85].
- •Platelet count <100×109/L.
- •Antinuclear antibody (ANA) confirmed positive and clinically significant.
- •Abnormal TSH with clinical significance.
- •Female during pregnancy and lactation or positive serum pregnancy test.
- •Patients with contraindication of MRI scan.
- •Take any product contains alcohol within 24 hours prior to dosing.
- •Have chocolate, any food or beverage that contains caffeine or xanthine within 24 hours prior to dosing.
- •Positive for urine drug screening or history of substance abuse for a period of 5 consecutive years before screening.
- •Any acute illness or concomitant medication from screening to first dosing.
- •As judged by the researcher, it is not suitable to join the clinical researcher.
研究组 & 干预措施
ZSP1601-Dose 2
Experimental
ZSP1601-50mg twice daily
干预措施: ZSP1601 (Drug)
ZSP1601-Dose 1
Experimental
ZSP1601-50mg once daily
干预措施: ZSP1601 (Drug)
ZSP1601-Dose 1
Experimental
ZSP1601-50mg once daily
干预措施: ZSP1601 Placebo (Drug)
ZSP1601-Dose 2
Experimental
ZSP1601-50mg twice daily
干预措施: ZSP1601 Placebo (Drug)
ZSP1601-Dose 3
Experimental
ZSP1601-100mg once daily
干预措施: ZSP1601 (Drug)
ZSP1601-Dose 3
Experimental
ZSP1601-100mg once daily
干预措施: ZSP1601 Placebo (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: ZSP1601 Placebo (Drug)
结局指标
主要结局
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo.
时间窗: Initiation of study treatment (Day 1) up to 2 weeks post-treatment.
severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)
次要结局
- MRI-PDFF(Baseline and Day 28.)
- TNF-α(Baseline and Day 28.)
- ALT(Baseline and Day 28.)
- AST(Baseline and Day 28.)
- Tmax(Day1 and day 14)
- Cmax(Day1 and day 14)
- t1/2z(Day1 and day 14)
- Rac of Cmax(Day1 and day 14)
- DF of ZSP1601 at steady status(Day1 and day 14)
- AUClast（AUC0-t）(Baseline (0h) and day 14)
- Rac of AUC(Day1 and day 14)
研究者
研究点 (1)
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