ACTRN12620001292965已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses and Food Effect of PRAX-562 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 112
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Female or male and between the ages of 18 and 55 years, inclusive.
- •- Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
- •- Medically healthy (without significant medical issues, e.g. high blood pressure)
排除标准
- •- Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug.
- •- Any abnormal ECG findings, laboratory value or physical examination findings
- •- Positive ethanol, drug screen or cotinine test
- •- Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 2 weeks
- •- Use of any experimental or investigational drug or device within 30 days
- •- Donation or loss of 400 mL or more of blood within 8 weeks and/or donation of plasma within 7 days
研究者
相似试验
尚未招募
1 期
A Study in Healthy Males and Females to Test How Different Doses of OPC-224333 are Tolerated (Arm 1)Neurological - EpilepsyEpilepsyACTRN12622000460707Otsuka Pharmaceutical Development & Commercialization, Inc72
尚未招募
不适用
A Phase 1 Study to Assess the Safety and Pharmacokinetics of GC1102 (Hepabig-Gene) in Healthy Male AdultsKCT0000473Green Cross33
已完成
1 期
A Phase 1, Single-Dose, Multiple-Dose, Food Effect and Drug-Drug Interaction Study of BPN14770Health ConditionJPRN-jRCT2031200182agata Tsutae112
招募中
不适用
A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PRAX-628 in Healthy Participants.Focal epilepsy10039911NL-OMON51482Praxis Precision Medicines112
已完成
1 期
A Phase 1 single ascending study in healthy Caucasian and Japanese Adult subjects to evaluate the Safety, Tolerability, and Pharmacokinetics of CSL346.DyslipidemiaHyperglycemiaACTRN12617001554358CSL Limited82