NCT06452693尚未招募1 期
A Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 162
- 试验地点
- 22
- 主要终点
- Serious adverse events (SAEs)
研究概览
简要总结
This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Subjects voluntarily participate in this study and sign informed consent;
- •Male and female ≥18 years old and ≤65 years old;
- •Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18~28 kg/m2;
- •Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml ≤ HBsAg quantification ≤ 5000 IU/ml;
- •The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;
- •The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures during the clinical trial period and long-term follow-up period, and specific contraceptive measures are shown in the appendix;
- •The treated patients need to meet the condition:The subject must have received oral nucleoside (acid) drug treatment and a stable treatment regimen;
- •Newly treated patients must meet the condition:During screening, the subjects had never received antiviral treatment for chronic hepatitis B B (oral nucleoside (acid) drugs and interferon), or had irregular antiviral treatment in the past, but had not received any antiviral treatment for chronic hepatitis B 3 months before enrollment.
排除标准
- •Pregnant and lactating women;
- •Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
- •Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
- •Individuals with a history of active pathological bleeding or a tendency towards bleeding;
- •Prescription medication has been used within 14 days prior to receiving the study drug;
- •Receive any preventive or attenuated vaccines within 14 days prior to receiving the study drug;
- •Blood donors or those who have lost a significant amount of blood within the first 3 months of screening, or those who have donated blood during the planned study period;
- •Subjects with a history of excessive alcohol consumption;
- •A history of alcohol or drug abuse within the 12 months prior to screening, or a positive drug screening result during screening;
- •Complicated with other infected disease;
- •Patients with significant liver fibrosis or cirrhosis before or during screening;
- •History of chronic liver diseases other than chronic HBV infection;
- •Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
- •Used immunosuppressive or immunomodulatory drugs and cytotoxic drugs within 6 months prior to the study medication;
- •During screening, subjects showed significant laboratory results abnormalities；
- •Screening for tumors with a history of malignancy within the first 5 years, excluding tumors that can be completely cured through surgical resection;
- •Uncontrollable chronic diseases;
- •History of intolerance to subcutaneous injection;
- •Participated in clinical studies of any drug or medical device within 3 months prior to drug administration or within 5 times the half-life of the investigational drug, or used the investigational drug;
- •Those considered unsuitable for enrollment by the investigators.
研究组 & 干预措施
TQA3038 injection/placebo
Experimental
100/0mg~400/0mg, subcutaneous injection, 2 weeks~8 weeks as a cycle, a total of 2 doses.
Nucleotide drugs: Oral, once a day, orally administered with food, for 16 weeks.
干预措施: TQA3038 injection/placebo (Drug)
Nucleotide drugs Control group
Active Comparator
Nucleotide drugs: Oral, once a day, orally administered with food, for 48weeks.
干预措施: Nucleotide drugs Control group (Drug)
结局指标
主要结局
Serious adverse events (SAEs)
时间窗: Baseline up to 16 weeks
The incidence of serious adverse events (SAEs) during treatment.
Hepatitis B virus surface antigen (HbsAg)
时间窗: Baseline up to 48 weeks
Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.
Adverse events (AEs)
时间窗: Baseline up to 16 weeks
The incidence of adverse events (AEs) during treatment.
次要结局
- Maximum Plasma Concentration (Cmax)(Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose)
- Time to Reach Maximum Plasma Concentration (Tmax)(Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose)
- Volume of distribution (Vd/F)(Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose)
- Apparent Plasma Clearance (CL/F)(Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose)
- Hepatitis B surface antigen (HBsAg)(Baseline up to 48 weeks)
- Hepatitis B E antigen (HBeAg)(Baseline up to 48 weeks)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose)
- The incidence and titer of anti drug antibodies (ADA)(Day1 before administration, Week 8, Week 16, and during withdrawal)
- Incidence of Neutralization antibody (Nab)(Day1 before administration, Week 8, Week 16, and during withdrawal)
- Apparent Terminal Elimination Half-life (t1/2)(Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose)
研究者
研究点 (22)
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