NCT05542979已完成1 期
A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple-dose HH-003 Injection in Treatment Naïve Participants With HBeAg-positive Chronic HBV Infection
Huahui Health11 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年8月5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
- 68
- 试验地点
- 11
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the safety, tolerability and pharmacokinetics of HH-003 injection in treatment-naive participants chronically infected with hepatitis B virus.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 45 years old
- •Body weight ≥ 45 kg for men and ≥ 40 kg for women, and 18 kg/m^2≤BMI≤28 kg/m^2
- •Positive serum HBsAg or HBV DNA for at least 6 months,or previous liver biopsy results confirm the Hepatitis B
- •HBeAg positive, and 2000 IU/mL<HBsAg<100,000 IU/mL
- •Have not received interferon treatment before, and have not received nucleotide/nucleoside analogue treatment within 6 months prior to Screening
排除标准
- •Positive test for hepatitis C antibody (HCV-Ab), treponema pallidum antibody (TP-Ab), or anti-HIV antibody (HIV-Ab)
- •Hemoglobin <100 g/L, platelets <100,000/mm^3 (100×10^9/L), absolute neutrophils count <1,500/mm^3 (1.5×10^9/L)
- •Serum albumin <35 g/L, international normalized ratio (INR)>1.5; serum creatinine >115 μmol/L, Glomerular Filtration Rate (GFR) <70 mL/min/1.73m^2(calculated by Modification of Diet in Renal Disease (MDRD) formula); uric acid>540 μmol/L; triglyceride>3.5mmol/L
- •Participants with a history of alcoholic liver disease, moderate or higher nonalcoholic fatty liver disease, autoimmune liver disease, Gilbert syndrome or other hereditary liver disease, drug-induced liver disease and other chronic liver diseases
- •Participants with a history of progressive liver fibrosis (eg: liver cirrhosis diagnosed by liver histopathological examination, or esophagogastric varices diagnosed by endoscopy)
- •Participants with confirmed or suspected decompensated HBV cirrhosis with complications of ascites, hepatic encephalopathy, gastroesophageal variceal bleeding, and Child-Pugh score of B~C, or with primary liver cancer
- •Alpha Fetoprotein (AFP) >50 ng/ml at screening or the suspected malignant liver mass indicated by imaging
- •Any previous or current malignant neoplasms
- •Breast-feeding or pregnant females
- •Participants who are not suitable to participate in this trial per the Investigator's judgment
研究组 & 干预措施
HH-003 Group
Experimental
干预措施: HH-003 injection (Drug)
Placebo Group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From the first dose of study drug until Day 57
Peak concentration (Cmax)
时间窗: From predose to Day 113
Area under the drug-time curve (AUC0-2W）
时间窗: From predose to Day 113
Area under the drug-time curve (AUClast)
时间窗: From predose to Day 113
Area under the drug-time curve (AUCinf)
时间窗: From predose to Day 113
次要结局
未报告次要终点
研究者
研究点 (11)
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