NCT05862623招募中1 期
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of AER-01 (Solution for Inhalation, Delivered Via Nebulizer): As a First-In-Human Single Ascending Dose in Healthy Volunteers (Part A), and a 7-day Multiple Ascending Dose in Healthy Volunteers(Part B)
Aer Therapeutics2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年5月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a first-in-human, randomized, double-blind, placebo-controlled, Phase 1 study of AER-01 (solution for inhalation, delivered via nebulizer) to assess the safety, tolerability and PK of AER-01. The study will be conducted in 2 parts: a single ascending dose (SAD) part in HVs (Part A) and a 7-day multiple ascending dose (MAD) part in HVs(Part B).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of unstable medical conditions or major surgical procedures over the 12 months prior to Screening.
- •History or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (excluding history of recurrent urinary tract infection), neurologic (excluding history of migraine), dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the PI or designee might obfuscate the study data.
- •History of malignancy of any type, other than in situ cervical cancer or surgically excised non melanomatous skin cancers, within 5 years before Screening. Part B Participants with COPD and Moderate Airflow Limitation
- •Has evidence of significant lung restriction on pulmonary function testing or a history of interstitial lung disease (including sarcoidosis and idiopathic pulmonary fibrosis), severe bronchiectasis, cystic fibrosis (asthma is not an exclusion.
研究组 & 干预措施
AER-01
Experimental
Specified dose on specified days
干预措施: AER-01 (Drug)
Placebo
Placebo Comparator
Specified dose on specified days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
Will be summarized by cohort, preferred term (PT), system organ class (SOC), severity, and relationship to IP.
次要结局
- Maximum Plasma Concentration [Cmax](Baseline to Day 2 (Part A), Baseline to Day 7 (Part B))
- Time to maximum concentration [Tmax](Baseline to Day 2 (Part A), Baseline to Day 7 (Part B))
- Area under the drug concentration-time curve from time 0 (time of dosing) extrapolated to infinity [AUC 0-inf](Baseline to Day 2 (Part A), Baseline to Day 7 (Part B))
研究者
研究点 (2)
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