NCT04423393已完成1 期
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV infection).
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
- •Male or female age 18 - 55
- •Weight 40-125 kg
排除标准
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- •History or evidence of drug or alcohol abuse
- •History of allergic reactions to monoclonal antibodies or antibody fragments
- •History of anaphylaxis
- •CHB Patients:
- •Inclusion Criteria:
- •Male or female age 18 - 65
- •Weight 40-125 kg
- •Chronic HBV infection for >/= 6 months
- •Exclusion Criteria:
- •Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
- •Significant fibrosis or cirrhosis
- •History or evidence of drug or alcohol abuse
- •History of chronic liver disease from any cause other than chronic HBV infection
- •History of hepatic decompensation
- •History of anaphylaxis
- •History of allergic reactions to monoclonal antibodies or antibody fragments
- •History of immune complex disease
- •Active infection with HIV, HCV or hepatitis Delta virus
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
VIR-3434
Experimental
干预措施: VIR-3434 (Biological)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Number of Participants With Clinical Laboratory Abnormalities
时间窗: Up to 280 days post-dose
次要结局
- Cmax(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose)
- Tmax(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose)
- AUClast(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose)
- t1/2(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose)
- Vz/F(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose)
- Vz(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose)
- CL/F(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose)
- CL(Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose)
- Number of Participants With ADA to VIR-3434(Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose)
- Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)(Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose)
- Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)(Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose)
- Titers (if Applicable) of ADA to VIR-3434(Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose)
研究者
研究点 (1)
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