NCT04416126已完成1 期
A Phase 1 Randomized, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Doses of ARCT-810 in Healthy Adult Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence, severity and dose-relationship of AEs
研究概览
简要总结
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in healthy adult subjects.
详细描述
This is a single ascending dose study of ARCT-810 in which approximately 30 subjects are planned to be enrolled. The length of each study participant is approximately 8 weeks from screening to last study visit.
Study participants will be allocated to one of the five different study groups (also called cohorts), to test different doses of ARCT-810. There will be 6 participants in each group. Within each cohort, subjects will be randomized 2:1 to receive ARCT-810 or placebo as an IV infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blinded, Placebo Controlled
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
- •Healthy males or females aged 18 to 65 at the time of informed consent.
- •Body weight ≤ 100Kg and body mass index <35 kg/m2
- •Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits and willing to refrain from taking protein supplements for the duration of the study.
- •Willing and able to comply with protocol-defined procedures and complete all study visits
- •Males must be surgically sterile or, if engaged in sexual relations with a female of child-bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of Study Drug. Females: must be non-pregnant and non-lactating and either: i. surgically sterile or ii. post-menopausal
排除标准
- •Clinically significant abnormalities in medical history
- •Screening laboratory results as follows:
- •ALT, AST, GGT, total bilirubin or alkaline phosphatase, > ULN.
- •Random blood glucose and/or HbA1c > ULN
- •Hemoglobin < LLN
- •Platelet count < 100x109/L
- •Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 calculated by Modification to Diet in Renal Disease [MDRD] study equation.
- •Urine protein:creatinine ratio (UPCR) > 50 mg/mmol
- •Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 7 days prior to Study Day 1
- •Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- •Uncontrolled hypertension (BP > 160/100 mm Hg)
- •Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
- •Recent (within 1 year) history of, or current drug or alcohol abuse
- •Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study
结局指标
主要结局
Incidence, severity and dose-relationship of AEs
时间窗: 4 weeks
Safety and tolerability of ARCT-810 assessed by determining the incidence, severity and dose-relationship of AEs by dose
次要结局
- Number of participants with changes in urine pharmacokinetic parameters after single dose of ARCT-810(Up to 24 hours)
- Number of participants with changes in plasma pharmacokinetic parameters after single dose of ARCT-810(Up to 15 days)
研究者
研究点 (1)
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