ACTRN12623001054606招募中1 期
A double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TX000045 in healthy participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
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
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Participants must meet the following criteria to be enrolled in this study:
- •Is a male or a female of non–childbearing potential between the ages of 18 and 55 years.
- •Is judged to be in good health based upon medical history, physical examination, vital signs, ECGs, and routine laboratory tests.
- •Has a BMI (body mass index) between 18 and 32 kg per meter square at screening.
- •Understands the study procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •Exclusion criteria
- •Participants are excluded from the study if any of the following criteria apply:
- •Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders at the discretion of the investigator.
- •Has any clinically significant physical examination abnormalities observed during the screening visit or would not be a good candidate for participation in the study in the opinion of the investigator.
- •Has clinically significant abnormal complete blood count, clinical chemistry, or urine analysis at screening or Day -1. In asymptomatic participants, any abnormal laboratory results, including creatine phosphokinase within 3 times the upper limit of normal with suspected cause due to rigorous physical activities, may be repeated once during the screening period.
- •Was hospitalized for any reason within 30 days of the screening visit.
- •Has any history of clinically significant renal, neurologic, gastrointestinal, hepatic, or respiratory disease. Note that subjects with fully resolved childhood asthma with no recurrence in adulthood may be enrolled.
- •Has a history of anaphylaxis or other significant allergy in the opinion of the investigator.
- •Has a history of clinically significant cardiovascular disease including arrhythmias, conduction abnormalities, or clinically significant abnormal vital signs.
- •Was previously administered relaxin or relaxin fusion proteins.
- •Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy (including specific immunotherapy) within 90 days or less than or equal to 5 half-lives (whichever is longer) of an investigational biologic drug, or less than or equal to 4 weeks for other investigational products, before the screening visit.
研究者
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