ACTRN12606000410550招募中1 期
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Center Trial to Assess the Safety, Tolerability, and Pharmacokinetics of AV411 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Avigen, Inc.
- 入组人数
- 16
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 70 Years（—）
- 性别
- All
入选标准
- •Nonsmoking.-No clinical abnormality in laboratory and urine analyses.-Normal renal function Glomerular Filtration Rate (GFR) >90 mL/min.-Liver enzymes less than twice the upper limit of normal.-Electrocardiogram within normal limits at screening.-Willing to use barrier contraceptive during the period of the study.-Negative pregnancy test on Study Day 1 for female subjects of child-bearing potential.
排除标准
- •Known hypersensitivity to Pinatos or its components.-Conditions which might affect drug absorption, metabolism or excretion.-Untreated mental illness, current drug addiction or abuse or alcoholism.-Donated blood in the past 90 days or have poor peripheral venous access.-Platelets <100,000 per mm3 or a history of thrombocytopenia.-Confirmed diagnosis of chronic liver disease.-Positive for HIV.-Female subjects who are pregnant or nursing mothers.
研究者
相似试验
已完成
Unknown
A Phase 1 study, oral VVZ2471 in healthy male volunteersKCT0008891Vivozon87
已完成
不适用
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study and an Open-Label Relative Bioavailability and Food Effect Study of VX-787 in Healthy Subjects10047438influenzaNL-OMON37724Vertex Pharmaceuticals56
尚未招募
1 期
A Phase 1, Randomized Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intermittent Consecutive Day Dosing Regimen of PRTX007 in Healthy Adultsassa VirusLassa VirusInfection - Other infectious diseasesACTRN12624000981527nited States Defense Threat Reduction Agency (DTRA)15
已完成
1 期
A Phase I, Randomised, Double-Blinded, Placebo Controlled, Safety and Pharmacokinetic Study of (Z)-Endoxifen in Healthy Female VolunteersEstrogen Receptor Positive (ER+) breast cancerCancer - BreastACTRN12619000961145Atossa Genetics AUS Pty Ltd25
已完成
1 期
A Phase I, Randomised, Double-Blinded, Placebo Controlled, Safety and Pharmacokinetic Study of (Z)-Endoxifen Tablets in Healthy Female VolunteersEstrogen Receptor Positive (ER+) Breast CancerCancer - BreastACTRN12619001623189Atossa Genetics Aus Pty Ltd12