NL-OMON49076已完成不适用
A randomized, placebo-controlled, double-blind, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of NX210 in healthy volunteers. - CS0332-190166 Axoltis
Axoltis Pharma0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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 99（—）
入选标准
- •Subject is a male or is a female of non-childbearing potential, aged between 18
- •and 55 years (inclusive).
- •A body weight of >=50.0 kg and <=90.0 kg (85.0 kg for Cohort 5 at the highest
- •dose) and a body mass index (BMI) of >=18.0 kg/m2 and <=30.0 kg/m2 at Screening.
- •Healthy as determined by the Investigator, based upon a medical evaluation
- •including medical history, physical examination, neurological examination, lab
- •tests and ECG performed at screening.
- •Subjects understand the study, can give written informed consent at Screening,
- •and are willing to comply with the requirements and restrictions of the study.
排除标准
- •Prior or ongoing medical condition, medical history, physical findings, ECG
- •findings, laboratory or vital signs abnormality that, in the Investigator's
- •opinion, could adversely affect the safety of the subject.
- •The subject has a current or recurrent disease (e.g., cardiovascular,renal,
- •liver, gastrointestinal, malignancy or other conditions) that could affect the
- •distribution, metabolism or excretion of the investigational product or could
- •affect clinical or laboratory assessments.
- •History of any clinically significant allergy, hypersensitivity or intolerance.
- •Subject with one or more of the following laboratory abnormalities at Screening
- •and between Screening and dosing: abnormal Alanine aminotransferase (AST),
- •abnormal aspartate aminotransferase (ALT) or abnormal alkaline phosphatase
- •levels (ALP) >=1.5 x upper limit of normal (ULN); total bilirubin >=1.5 x ULN; or
- •clinically significant laboratory abnormalities or abnormalities which are
- •deemed to interfere with the ability to interpret study data. A repeat is
- •allowed once to determine eligibility.
研究者
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