NCT03844906已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Multiple Doses of SAGE-718 Using Ketamine Challenge to Evaluate the Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy 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
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
研究概览
简要总结
This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening.
- •Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.
排除标准
- •Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
- •Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
- •Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.
研究组 & 干预措施
SAGE-718
Experimental
干预措施: SAGE-718 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
时间窗: From Day 1 through Day 11
Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
时间窗: From Day 1 through Day 11
次要结局
- Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.(Between Baseline and Day 26)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A Study to Evaluate SGB-3403 in Healthy Volunteers and Subjects With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)HyperlipidemiasNCT06239714Suzhou Sanegene Bio Inc.64
已完成
1 期
A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult VolunteersHealthy VolunteersNCT03936166Crinetics Pharmaceuticals Inc.57
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STSP-0902 in Healthy SubjectsOligozoospermiaAsthenozoospermiaNCT06563713Staidson (Beijing) Biopharmaceuticals Co., Ltd40
已完成
1 期
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy SubjectsHealthy VolunteerNCT03771586Supernus Pharmaceuticals, Inc.22
已完成
1 期
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisNCT02531178AbbVie8