JPRN-jRCT2080225100已完成1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Study Assessing the Safety and Tolerability of SEP-363856 in Japanese Subjects with Schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •(1) Subjects who voluntarily provide written consent to participate in the study. If the subject is considered a minor at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
- •(2) Subject who has schizophrenia diagnosed by DSM-5, diagnostic criteria, and in the opinion of the Investigator has been clinically stable.
- •(3) Subject who has body weight >= 40.0kg and body mass index (BMI) >= 18.5.
- •(4) Female subjects who are premenopausal and of childbearing potential must have a negative serum pregnancy test result.
- •(5) Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to use adequate and reliable contraception.
排除标准
- •(1) Subjects who become strongly affected by potent central nervous system depressants (including barbiturate) as considered by the Investigator.
- •(2) Subjects who have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
- •(3) Subjects with active suicidal ideation or those with a suicide attempt history.
- •(4) Subjects with a history or complication(s) of hypersensitivity to any medication.
- •(5) Subjects with a history or complication(s) of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
- •(6) Subjects who have previous or existing infection with human immunodeficiency virus (HIV) at screening.
- •(7) Subjects who have a positive syphilis serological test, Hepatitis B virus surface (HBs) antigen or Hepatitis C virus (HCV) antibody at screening.
研究者
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