NCT07595159已完成1 期
A Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BW-20507 in Chinese Healthy Subjects and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity in Chinese Subjects With Chronic HBV Infection
Shanghai Argo Biopharmaceutical Co., Ltd.4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年6月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
Phase 1 Study of BW-20507 in Healthy Subjects and Patients With Chronic Hepatitis B. Ia involved a single ascending dose study where healthy participants were administered one dose of BW-20507 or placebo subcutaneously. Ib involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered with multiple doses of BW-20507 SC
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
- Double (Participant, 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
- 是
入选标准
- •healthy male or female participants Ib：
- •Males or females aged 18 to 65 years (inclusive) at the time of informed consent
- •Body mass index (BMI) ≥18 and ≤28 kg/m2, with body weight >50 kg (male) or 45 kg (female)
- •Serum hepatitis B surface antigen (HBsAg) positive for ≥6 months at screening
排除标准
- •unhealthy male or female participants
- •Any clinically significant chronic diseases of cardiovascular, respiratory, endocrine, immune, renal, gastrointestinal, skin, hematologic, neuropsychiatric, or other systems (excluding chronic HBV infection), or laboratory test abnormal (unrelated to chronic HBV infection) that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
- •Any other clinically significant chronic liver disorders in addition to chronic HBV infection, including but not limited to: alcoholic liver disease, moderate or above fatty liver, autoimmune liver disease, hereditary metabolic liver disease, etc.
- •Significant hepatic fibrosis or hepatic cirrhosis, i.e., FibroScan >9.0 kPa within 1 month prior to screening, or liver paracentesis pathology showing advanced hepatic fibrosis (Metavir F3) or hepatic cirrhosis (Metavir F4) within 1 year prior to screening
研究组 & 干预措施
Ia
Experimental
干预措施: Placebo (Drug)
Ib
Experimental
干预措施: Placebo (Drug)
Ia
Experimental
干预措施: BW-20507 (Drug)
Ib
Experimental
干预措施: BW-20507 (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 12 weeks
次要结局
- Cmax: The maximum concentration of BW-20507 in plasma(Up to 12 weeks)
- Tmax: The time from dosing to maximum plasma concentration of BW -20507(Up to 12 weeks)
- T1/2: Terminal half-life for BW -20507 after dosing(Up to 12 weeks)
- HBsAg level change from baseline(Up tp 48 weeks)
- AUC: The area under the BW-20507 plasma concentration-time curve(Up to 12 weeks)
研究者
研究点 (4)
Loading locations...
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