A Randomized, Double-blinded, Placebo-controlled, Phase IIa Study of TQ-A3334 Combined With Entecavir in the Treatment of Untreated or HBV DNA Negative Subjects With Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cmax
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects 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
- 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
- •18 and 65 years old ;
- •HBsAg positive at least for 6 months ;
- •HBeAg positive chronic hepatitis B, HBV DNA > 10^5 copies/ml;
- •Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN;
- •New diagnosed chronic hepatitis B subjects;
排除标准
- •1.Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;
研究组 & 干预措施
TQ-A3334 combined with entecavir
Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks
干预措施: TQ-A3334 (Drug)
TQ-A3334 combined with entecavir
Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks
干预措施: Entecavir Tablet (Drug)
Placebo combined with entecavir
Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks
干预措施: Placebo (Drug)
Placebo combined with entecavir
Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks
干预措施: Entecavir Tablet (Drug)
结局指标
主要结局
Cmax
时间窗: Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).
Tmax
时间窗: Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.
AUC0-t
时间窗: Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.
Cytokine
时间窗: Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7.
Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on.
次要结局
- HBV biomarker(Day 1 pre-dose, day 84, day 168, day 336 post-dose.)
- Lymphocyte function(Hour 0 pre-dose, day 56, day 84, day 168 at post-dose.)