An Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX464 in HIV-1 Seronegative and Seropositive Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abivax S.A.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
研究概览
简要总结
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.
详细描述
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics. The site will screen and enroll 12 HIV-infected subjects who will receive 150 mg ABX464 orally once daily for 28 days (Cohort 1). Following completion of this cohort a further 24 subjects will be enrolled: 12 HIV-uninfected subjects will receive 50 mg ABX464 orally once daily for 28 days (Cohort 2) and 12 HIV-infected subjects (Cohort 3) who will 50 mg ABX464 orally once daily for 84 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of investigational products;
- •Acute or chronic infectious disease other than HIV infection (include but not limited to viral hepatitis such as hepatitis B, hepatitis C, active tuberculosis, active syphilis [i.e. currently treated].
- •Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (CNS) pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
- •Severe hepatic impairment;
- •Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
研究组 & 干预措施
ABX464 150mg
ABX464, 50mg per Capsule Three Capsules per day for 28 days
干预措施: ABX464 150mg (Drug)
ABX464 50mg for 28 days
ABX464, 50mg per Capsule One Capsule per day for 28 days
干预措施: ABX464 50mg (Drug)
ABX464 50mg for 84 days
ABX464, 50mg per Capsule One Capsule per day for 84 days
干预措施: ABX464 50mg (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
时间窗: Day 1, Day 28 and Day 84
Pharmacokinetics parameters
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
时间窗: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
时间窗: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
时间窗: Day 1, Day 28, Day 56, Day 84 and Day 112
Pharmacokinetic parameters
Area Under the Curve (AUC) of ABX464 in Sera
时间窗: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Maximum Observed Concentration (Cmax) of ABX464 in Sera
时间窗: Day 1, Day 28 and day 84
Pharmacokinetic parameters
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
时间窗: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
时间窗: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
时间窗: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
时间窗: Day 1, Day 28, Day 56, Day 84 and Day 112
Pharmacokinetic parameters
次要结局
- Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)(Day 28, Day 56, Day 84 and Day 112)
- CD4+ Counts (Cell/mm^3)(Day 28, Day 35, Day 56, Day 84, Day 91 and Day 112)
- Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)(Day 28, Day 56, Day 84 and Day 112)