Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102Injection in Healthy Subjects and Hepatitis B E Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: a Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
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
- 是
入选标准
- •Healthy Participants SAD:
- •Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
- •Participants were healthy individuals;
- •Participants promise to have no plans to have a child, donate sperm or eggs and voluntarily take effective non-drug contraception measures during the trial and within 3 months after the end of the trial;
- •Participants with Chronic HBV infection, MAD:
- •Chronic HBV infection, and HBeAg negative;
- •Patients who had received antiviral therapy for at least one year before screening and stabilization therapy with nucleoside (nucleotide) reverse transcriptase inhibitors for ≥ 3 months before screening (nucleoside (nucleotide) reverse transcriptase inhibitors;
排除标准
- •Participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease;
- •Participants with major trauma or major surgery within 3 months before trial screening;
- •Participants with a history of drug allergy;
- •Participants who used any drugs before trial screening or are using any drugs, including vitamins and Chinese herbal medicines;
- •Participants with abnormal results of ECG examination, laboratory test in the screening period which were judged as clinically significant;
- •Participants who cannot tolerate subcutaneous injection;
- •Patients with a previous clinical diagnosis of liver cirrhosis, or a history of alcoholic liver disease, autoimmune liver disease, inherited metabolic liver disease, and other liver diseases;
- •Participants with a clinically significant acute infection;
- •Women who were pregnant or lactating or had a positive pregnancy test result;
研究组 & 干预措施
Part A (Healthy participants administered with HT-102 or placebo)
Healthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously
干预措施: HT-102 (Drug)
Part A (Healthy participants administered with HT-102 or placebo)
Healthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously
干预措施: Placebo (Drug)
Part B (Patients with CHB administered with HT-102 or placebo)
Patients with chronic hepatitis B in all dose groups were randomly assigned to receive 5 dose of HT-102 or placebo subcutaneously every week.
干预措施: HT-102 (Drug)
Part B (Patients with CHB administered with HT-102 or placebo)
Patients with chronic hepatitis B in all dose groups were randomly assigned to receive 5 dose of HT-102 or placebo subcutaneously every week.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: From administration to the end of treatment at 8 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
时间窗: From administration to the end of treatment at 8 weeks
次要结局
- Apparent Plasma Clearance (CL/F)(From administration to the end of treatment o at 10 weeks)
- Maximum Plasma Concentration (Cmax)(From administration to the end of treatment o at 10 weeks)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(From administration to the end of treatment o at 10 weeks)
- Apparent Terminal Elimination Half-life (T1/2)(From administration to the end of treatment o at 10 weeks)
- Apparent volume of distribution（Vd/F）(From administration to the end of treatment o at 10 weeks)
- Change of Serum HBsAg From Baseline(From administration to the end of treatment o at 10 weeks)
- Change of Serum HBV DNA From Baseline(From administration to the end of treatment o at 10 weeks)
- Change of Serum HBV RNA From Baseline(From administration to the end of treatment o at 10 weeks)
- Change of Serum HBcrAg From Baseline(From administration to the end of treatment o at 10 weeks)
- Change of Serum HBcAb From Baseline(From administration to the end of treatment o at 10 weeks)
- Titers of Anti-drug Antibody (ADA) to HT-102(From administration to the end of treatment o at 10 weeks)