NCT05276570已完成1 期
A Phase 1/2a Study Evaluating the Effects of ARO-RAGE Inhalation Solution in Healthy Subjects and Patients With Inflammatory Lung Disease
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
- 127
- 试验地点
- 11
- 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, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease (asthma). In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with asthma will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
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, Care Provider, Investigator)
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
- •Normal pulmonary function tests at Screening (NHVs only)
- •Confirmed diagnosis of asthma based on source verifiable medical record (asthma patients only)
- •No abnormal finding of clinical relevance at Screening (other than asthma for asthma patients)
- •Stable dose of asthma controller medications prior to Screening (asthma patients only)
- •If on allergen-specific immunotherapy, participants must be on a stable maintenance dose
- •Non-smoking
- •Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 12 weeks following the last dose of study drug
- •Willing to provide written informed consent and to comply with study requirements
排除标准
- •Acute lower respiratory infection or asthma exacerbation within 30 days prior to first dose
- •Positive COVID-19 test during Screening window
- •Use of immunosuppressive medication within 90 days prior to first dose
- •Receipt of any intranasal vaccine within 30 days prior to first dose
- •Use of systemic corticosteroid therapy within 90 days prior to first dose
- •Clinically significant health concerns (other than asthma in asthma patients)
- •Human Immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
- •Uncontrolled hypertension
- •Unwilling to limit alcohol consumption to within moderate limits for the duration of the study
- •Use of illicit drugs
- •Use of an investigational agent or device within 30 days prior to first dose
- •Note: additional inclusion/exclusion criteria may apply per protocol
研究组 & 干预措施
Placebo
Placebo Comparator
(0.9% NaCl)
干预措施: Placebo (Drug)
ARO-RAGE
Experimental
ARO-RAGE Inhalation
干预措施: ARO-RAGE (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)
次要结局
- 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 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- PK of ARO-RAGE: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount Excreted; Ae)(Through 24 hours post-dose)
- 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 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- 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)
- PK of ARO-RAGE: Time to Maximum Observed Plasma Concentration (Tmax)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- 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 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- 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 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- Change from Baseline Over Time in Forced Expiratory Volume (FEV1)(Baseline through EOS (up to 113 days) or until serum soluble receptor for advance glycation end products (sRAGE) is ≥ 70% of baseline value)
- 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)
- 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 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- 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 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- 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 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
- PK of ARO-RAGE: Percentage of Administrated Drug Recovered in Urine Over 0 to 24 hours(Through 24 hours post-dose)
- PK of ARO-RAGE: Renal Clearance (CLr)(single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma)
研究者
研究点 (11)
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