NCT03596697已完成1 期
A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects
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
- 92
- 试验地点
- 2
- 主要终点
- Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
研究概览
简要总结
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of giving written informed consent
- •Willing and able to complete all study requirements
- •Healthy male or female between 18 and 55 years of age (inclusive);
- •Body mass index 16 to 32 kg/m2 (inclusive);
排除标准
- •Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
- •Current or history of abuse of alcohol or illicit drugs
- •Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug.
- •Additional Exclusion Criteria for HBV Pilot Subjects Only:
- •Evidence of significant liver fibrosis or cirrhosis
- •History of NAFLD or NASH
- •Positive test for HDV
研究组 & 干预措施
CRV431
Experimental
Either single or multiple doses of varying dose levels
干预措施: CRV431 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
TDF
Experimental
300 mg TDF
干预措施: TDF (Drug)
结局指标
主要结局
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
时间窗: 56 days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy VolunteersHereditary AngioedemaNCT05178355KalVista Pharmaceuticals, Ltd.108
已完成
1 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy ParticipantsHealthy ParticipantsNCT06491550AstraZeneca91
终止
1 期
Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis SubjectsHealthyRheumatoid ArthritisNCT01962337Five Prime Therapeutics, Inc.66
已完成
1 期
A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy VolunteersRespiratory DisordersNCT01818024GlaxoSmithKline54
终止
1 期
A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus InfectionHepatitis CNCT03253471Alios Biopharma Inc.24