NCT07748026尚未招募1 期
A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART105 in Healthy Adult Participants
Arnatar Therapeutics, Inc.0 个研究点目标入组 24 人开始时间: 2026年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Incidence of AEs
研究概览
简要总结
The goal of this clinical trial is to learn if ART105 is safe in healthy adult participants. It will also learn about the PK and PD profiles of ART105. The main questions it aims to answer are:
Is ART105 safe and tolerable in adult participants? How does the ART105 influence the urine PC1 level of participants?
Participants will:
recieve single dose of ART105 and visit the clinic 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary participation with signed written informed consent (ICF) .
- •Male or female, aged 18-55 years (inclusive).
- •males ≥ 50 kg; females ≥ 45 kg; and BMI between 19 and 26 kg/m² (inclusive).
- •No history of clinically significant abnormalities.
- •Normal or not clinically significant (NCS) findings at screening for vital signs, physical exam, lab tests, 12-lead ECG, and abdominal ultrasound.
- •Participants of childbearing potential (or males with partners of childbearing potential) must agree to use highly effective contraception.
排除标准
- •Any uncontrolled or severe disease, or any medical or surgical condition that may interfere with the participant's participation in the clinical trial
- •History of hypersensitivity to oligonucleotide drugs, or known hypersensitivity to the investigational product or any of its excipients
- •Use of any ASO or siRNA drugs within 12 months prior to the first dose
- •History of alcohol abuse
- •History of drug or substance abuse, or a positive urine drug abuse screening test
- •Major surgery within 3 months prior to the administration of the investigational product or planned elective surgery during the study period.
- •Use of any prescription medications, over-the-counter (OTC) drugs, or herbal medicines within 14 days prior to the administration of the investigational product, or within 5 half-lives of the drug (whichever is longer).
- •Enrollment in or ongoing participation in any other clinical trial within 3 months or 5 half-lives (whichever is longer) prior to the administration of the investigational product
- •Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), or Treponema pallidum antibody (syphilis).
- •Occurrence of acute illness or use of concomitant medications from the screening phase until prior to the administration of the investigational product.
- •Consumption of any alcohol-containing products or a positive breath alcohol test within 48 hours prior to the administration of the investigational product.
- •Participants who, in the investigator's opinion, have other factors that make them unsuitable for participation in this study.
研究组 & 干预措施
first dose level
Experimental
ART105 OR Placebo
干预措施: ART105 (Drug)
first dose level
Experimental
ART105 OR Placebo
干预措施: Placebo (Drug)
second dose level
Experimental
ART105 OR Placebo
干预措施: ART105 (Drug)
second dose level
Experimental
ART105 OR Placebo
干预措施: Placebo (Drug)
third dose level
Experimental
ART105 OR Placebo
干预措施: ART105 (Drug)
third dose level
Experimental
ART105 OR Placebo
干预措施: Placebo (Drug)
fourth dose level
Experimental
ART105 OR Placebo
干预措施: ART105 (Drug)
fourth dose level
Experimental
ART105 OR Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of AEs
时间窗: Baseline to Day 85
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
次要结局
- Plasma maximum observed concentration (Cmax) of ART105(Baseline to Day 3)
- Plasma time to maximum observed concentration (Tmax) of ART105(Baseline to Day 3)
- Plasma half-life (t½) of ART105(Baseline to Day 3)
- Plasma area under the concentration-time curve up to 24 hr post dose (AUC0-24) of ART105(Baseline to Day 3)
- Fraction of ART105 excreted in the urine (fe)(Baseline to Day 3)
- Total amount of ART105 excreted in the urine (Ae)(Baseline to Day 3)
- PD biomarkers change(Baseline to Day 85)
研究者
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