NCT05763576终止1 期
A Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Percentage of Healthy Volunteers With Adverse Events
研究概览
简要总结
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 volunteers:
- •Healthy participants
- •Body mass index (BMI) between 18 and 32 kg/m^2
- •CHB participants:
- •CHB infection (HBsAg-positive for >/= 6 months)
- •On NUC (ETV, TAF, or TDF) monotherapy for >/= 12 months
- •Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
- •BMI between 18 and 32 kg/m^2
排除标准
- •Healthy volunteers:
- •History of any clinically significant disease
- •Concomitant disease that could interfere with treatment or conduct of study
- •Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing (whichever is longer)
- •CHB participants:
- •Evidence of liver cirrhosis or decompensated liver disease
- •History or suspicion of hepatocellular carcinoma (HCC)
- •History or evidence of a medical condition associated with chronic liver disease other than HBV infection, or clinically significant and not adequately controlled non-hepatic disease
- •History of or currently receiving any systemic anti-neoplastic or immune-modulatory treatment within the 8 weeks prior to the first dosing or the expectation that such treatment will be needed at any time during the study.
研究组 & 干预措施
RO7565020
Experimental
干预措施: RO7565020 (Drug)
RO7565020
Experimental
干预措施: Nucleos(t)ide analogue (NUC) treatment (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Healthy Volunteers With Adverse Events
时间窗: Up to 104 weeks
Percentage of Participants With Chronic Hepatitis B With Adverse Events
时间窗: Up to 104 weeks
次要结局
- Serum Concentrations of RO7565020(Up to 104 weeks)
- Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)(Up to 104 weeks)
- Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints(Up to 104 weeks)
- Percentage of Participants With HBsAg Loss(Up to 104 weeks)
- Percentage of Participants With HBsAg Seroconversion(Up to 104 weeks)
- Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline(Up to 104 weeks)
- Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline(Up to 104 weeks)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
1 期
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy VolunteersInterstitial Lung DiseaseNCT04415671AdAlta Limited50
招募中
1 期
Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid TumorsAdvanced Solid TumorNCT06598800BeOne Medicines153
终止
1 期
Dose Finding Study of TNO155 in Adult Patients With Advanced Solid TumorsNCT03114319Novartis Pharmaceuticals227
终止
1 期
A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid TumorsNCT05904496BeiGene44
终止
1 期
A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or AmplificationNCT06585488BeOne Medicines47