A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.
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
- 否
入选标准
- •Male or female age 18 - 65;
- •Weight ≥ 40 kg to ≤ 125 kg;
- •Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months;
排除标准
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
- •Significant fibrosis or cirrhosis;
- •History or evidence of drug or alcohol abuse;
- •History of intolerance to SC injection;
- •History of chronic liver disease from any cause other than chronic HBV infection;
- •History of hepatic decompensation;
研究组 & 干预措施
VIR-2218
Drug: VIR-2218 VIR-2218 given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Placebo
Drug: Placebo Saline given by subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (TEAEs)
时间窗: up to 48 weeks
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Clinical Assessments Including But Not Limited to Laboratory Test Results
时间窗: up to 48 weeks
Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs
次要结局
- PK: Maximum Plasma Concentration(Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).)
- PK: Time to Reach Maximum Plasma Concentration(Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).)
- Number of Participants With Serum HBsAg Loss(up to 48 weeks)
- Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months(up to 48 weeks)
- Number of Participants With Anti-HBs Seroconversion at Any Timepoint(up to 48 weeks)
- PK: Percent of Area Extrapolated From AUC Last to Infinity(Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).)
- PK: Apparent Terminal Elimination Half-life(Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).)
- PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint(Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).)
- PK: Area Under the Plasma Concentration Versus Time Curve to Infinity(Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).)
- PK: Apparent Volume of Distribution(Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).)
- Maximum Change of Serum HBsAg From Baseline(up to 16 weeks)
- For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint(up to 48 weeks)
- PK: Apparent Plasma Clearance(Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).)