ACTRN12623000074695终止1 期
A Double-Blind, Randomized, Placebo-Controlled, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AB-161 Following Oral Administration in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Subject must be 18 (or other appropriate age of consent) to 50 years of age, inclusive, at the time of signing the informed consent. Healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results.
- •2. Body mass index (BMI) more than 18 kg per meter square and less than 35 kg per meter square.
- •3. A male subject is eligible to participate if he does not have a female partner who is pregnant or who intends to become pregnant during the study. Male subjects must agree to use contraception as outlined in the protocol.
- •4. A female subject is eligible to participate only if she is a NOT a women of childbearing potential (WOCBP).
- •5. Ability to review and capable of giving signed informed consent which includes compliance with all protocol-specified visit schedules and requirements
排除标准
- •1. A history of clinically significant endocrine, gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, cardiovascular, psychiatric or neurologic disorders.
- •2. Clinically significant ECG abnormalities, blood pressure or laboratory abnormalities, confirmed by repeat.
- •3. Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV confirmed by polymerase chain reaction (PCR). Evidence of prior HBV vaccination (positive HbsAb) is not exclusionary, and subjects with documented resolved HBV infection (HBsAg and HBV DNA negative) may participate.
- •4. Subjects who smoke or meet the protocol criteria for substance abuse.
- •5. Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are WOCBP, pregnant or breastfeeding.
研究者
相似试验
已完成
1 期
A Phase I Study to evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic profile of single and multiple dose of ANB019 in Healthy Subjects and Psoriasis Patients.Plaque PsoriasisACTRN12617000369325AnaptysBio Pty Ltd87
已完成
1 期
A Single and Multiple Dose Study to Determine the Safety and Tolerability of GBT021601 in Healthy Adult Volunteers - Part ABlood - Haematological diseasesHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersSickle Cell DiseaseACTRN12620001324909inear Clinical Research Ltd64
撤回
1 期
A Study to investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AB-452 in Healthy Subjects and Subjects with Chronic HBV InfectioACTRN12618001438246Arbutus Biopharma Corporation76
终止
1 期
A study to investigate the Safety, Tolerability, and Pharmacokinetics of AB-506 in Healthy Subjects and Subjects with Chronic HBV InfectioChronic HBV InfectionInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12618000987268Arbutus Biopharma Corporation57
已完成
1 期
A Study of JNJ-75220795 in Japanese ParticipantsFatty LiverJPRN-jRCT2071210066akano Masayoshi27