NCT05533294已完成1 期
A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-RAGE Injection in normal healthy volunteers.
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
- Quadruple (Participant, Care Provider, 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
- •Normal pulmonary function tests at Screening prior to sputum induction
- •Normal 12-lead electrocardiogram (ECG) at Screening
- •Non-smoking
- •Able to produce an induced sputum sample at Screening
- •Participants of child-bearing potential (male and female) must use highly effective contraception and cannot donate sperm or eggs during the study or for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Women must have a negative pregnancy test and cannot be breastfeeding
- •Willing to provide written informed consent and to comply with study requirements
排除标准
- •Acute lower respiratory infection within 30 days prior to first dose and/or acute upper respiratory infection within 7 days prior to first dose
- •Positive COVID-19 test during Screening window
- •Chronic or acute infection that is clinically significant or requires treatment with systemic antibiotics, antivirals, antifungals, or antiparasitics within 30 days prior to first dose
- •Any history of chronic pulmonary disease
- •Use of immunosuppressive medication within 90 days prior to first dose
- •Receipt of any intranasal vaccine within 30 days prior to first dose
- •Human Immunodeficiency virus (HIV) infection, seropositive fo Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
- •Uncontrolled hypertension
- •Use of illicit drugs
- •Unwilling to limit alcohol consumption to within moderate limits for the duration of the study
- •Use of an investigational agent or device within 30 days prior to first dose
- •Prior use of any formulation of ARO-RAGE
- •Note: additional inclusion/exclusion criteria may apply per protocol
研究组 & 干预措施
ARO-RAGE
Experimental
single or multiple doses of ARO-RAGE by subcutaneous (sc) injection
干预措施: ARO-RAGE Injection (Drug)
Placebo
Placebo Comparator
placebo calculated volume to match active treatment by sc injection
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: From first dose of study drug through the end of study (EOS; up to 113 days or until serum soluble receptor for advance glycation end products [SRAGE] is ≥70% of baseline value, whichever is later)
次要结局
- Change from Baseline Over Time in Forced Expiratory Volume (FEV1)(Baseline through EOS (up to 113 days or until serum SRAGE is ≥70% of baseline value, whichever is later))
- PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to 24 Hours (AUC0-24)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29)
- PK of ARO-RAGE: Terminal Elimination Half-Life (t1/2)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29)
- PK of ARO-RAGE: Apparent Terminal-Phase Volume of Distribution (VZ/F)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29)
- Change from Baseline Over Time in Forced Vital Capacity (FVC)(Baseline through EOS (up to 113 days or until serum SRAGE is ≥70% of baseline value, whichever is later))
- PK of ARO-RAGE: Maximum Observed Plasma Concentration (Cmax)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29)
- Change from Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO)(Baseline through EOS (up to 113 days or until serum SRAGE is ≥70% of baseline value, whichever is later))
- PK of ARO-RAGE: Apparent Systemic Clearance (CL/F)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29)
- PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to the Last Quantifiable Plasma Concentration (AUClast)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29)
- PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity (AUCinf)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29)
研究者
研究点 (1)
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