NL-OMON53619已完成不适用
A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers - CS0388-220214 Phase 1 clinical trial of IV GH002 in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
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
- 18 至 64（—）
入选标准
- •1. Is informed about the trial, has given informed consent in writing, and is
- •willing and able to comply with all requirements and rules of the trial.
- •2. Is in the age range between 18 and 45 years (inclusive) at the time of
- •informed consent.
- •3. Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at
排除标准
- •- Has any current or past clinically significant condition (e.g., severe
- •infection, severe pulmonary disease, uncontrolled hypertension, uncontrolled
- •diabetes, severe cardiovascular disease, myocardial infarction or clinically
- •significant arrythmia within the past year, severe hepatic or severe renal
- •failure, brain disorder [including seizure, stroke, dementia, degenerative
- •neurologic diseases, meningitis, encephalitis, and head injury with loss of
- •consciousness]) that may interfere with the interpretation of the trial
- •results, constitute a health risk for the subject, or that otherwise renders
- •the subject unsuitable for the trial according to the investigator*s judgement.
- •- Current or previously diagnosed psychiatric disorder (e.g., a history of
- •major depressive disorder [MDD], bipolar disorders, psychotic disorders,
- •post-traumatic stress disorder [PTSD], obsessive compulsive disorder, autism
- •spectrum disorder, borderline personality disorder, clinically significant
- •intellectual disability).
- •- Has one or more first degree relatives with a current or prior diagnosis of
- •bipolar disorder, psychotic disorder or other mood disorder (including MDD)
- •with psychotic features.-. Has one or more first-degree relatives with current
- •or past history of seizures (uncomplicated childhood febrile seizures with no
- •sequelae are not exclusionary).
- •- If a smoker, is unwilling or unable to abstain from cigarette smoking or
- •vaping for the duration of stay at the trial site (nicotine replacement therapy
- •is permitted).
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