NCT07771140招募中1 期
A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Trial With Single and Multiple Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of HECN30227 Injection in Healthy Volunteers and Subjects With Chronic Hepatitis B
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of Adverse Events In Part 1
研究概览
简要总结
To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.
- •Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg.
- •Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by the investigator to be clinically insignificant.
- •Female subjects of childbearing potential or male subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug.
- •Subjects must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide) for at least 6 months prior to screening.
- •HBV DNA < 90 IU/mL at screening.
- •HBsAg > 100 IU/mL at screening.
- •Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline.
排除标准
- •Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
- •Subjects with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods).
- •Subjects with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing.
- •Subjects with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing.
- •Subjects who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to screening; or those with a history of blood transfusion or blood product administration.
- •Subjects who participated in another clinical trial within 3 months prior to screening.
- •Subjects who develop an acute illness (e.g., acute respiratory disease) or receive concomitant medication from the time of signing the informed consent form to prior to the first dose.
- •Subjects who are breastfeeding or have a positive serum pregnancy test result.
- •Subjects with significant hepatic fibrosis or liver cirrhosis.
- •Subjects with a history of hepatic decompensation manifestations or disease at screening or in the past, including but not limited to ruptured esophageal and gastric variceal bleeding, ascites, hepatic encephalopathy, etc.
- •Subjects diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present.
- •Subjects with international normalized ratio (INR) >1.5, or platelet count <90×10⁹/L, or serum albumin <35 g/L at screening.
- •Subjects with alpha-fetoprotein (AFP) >50 ng/mL at screening.
- •Subjects with endogenous creatinine clearance (CLcr) <60 mL/min/1.73 m² at screening.
- •Subjects receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening.
- •Subjects whom the investigator considers unsuitable for participation in this trial for any other reasons.
结局指标
主要结局
Number of Adverse Events In Part 1
时间窗: 85 days
A summary of adverse events, including Serious Adverse Events(SAEs)
Number of Adverse Events In Part 2
时间窗: 169days
A summary of adverse events, including Serious Adverse Events(SAEs)
次要结局
- Maximum Change of Serum HBsAg From Baseline(24 weeks)
- Peak Plasma Concentration (Cmax) of single dose(48 h)
- Peak Plasma Concentration (Cmax) of Multiple dose(57 days)
- Area under the plasma concentration-time curve(AUC0-t）(57 days)
- Time to the peak plasma concentration (Tmax)(57 days)
研究者
研究点 (1)
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