A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
2026年7月27日 更新者：Revagenix, Inc.
A Sequential, Phase 1a/1b, Double-blind, 2-part Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Rev-56 for Inhalation Compared With Placebo in Healthy Adult Participants and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic Pseudomonas Aeruginosa
This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants and non-cystic fibrosis bronchiectasis (NCFB) patients with P. aeruginosa, respectively.
Phase 1a (Part A) will evaluate single doses of inhaled Rev-56 in adult healthy participants and includes up to 5 cohorts. Eligible participants will be randomized to active treatment or placebo in a 3:1 randomization scheme.
Phase 1b (Part B) will evaluate the safety, tolerability, microbiological response, and pharmacokinetics of multiple doses of inhaled Rev-56 in NCFB patients with P. aeruginosa and includes 2 cohorts evaluating once daily dosing and twice daily dosing, respectively. Eligible participants will be randomized to active treatment or placebo in a 2:1 randomization scheme.
研究概览
研究类型
介入性
注册 (估计的)
64
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Chrissy Morgenthaler
- 电话号码：619-512-3538
- 邮箱：revagenixclinicaltrials@revagenix.com
学习地点
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Florida
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Miami、Florida、美国、33136
- 招聘中
- Syneos Health Miami
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria (Healthy Participants):
- Healthy male and female participants aged 18 to 55 years, inclusive
- Body mass index > 18 to ≤ 32 kg/m^2
- Forced expiratory volume in 1 second (FEV1) ≥ 80%
- Creatinine clearance ≥ 90 mL/min
- Normal laboratory values and physical exam at screening, or Grade 1 abnormalities that are not clinically significant
Inclusion Criteria (NCFB Patients with P. aeruginosa):
- Male and female NCFB patients aged 18 to 80 years, inclusive
- Bronchiectasis confirmed by prior computerized tomography (CT) scan
- Chronic P. aeruginosa infection (≥ 2 positive cultures within prior 12 months)
- Screening sputum culture positive for P. aeruginosa at ≥ 10^4 CFU/mL
- FEV1 ≥ 50% (post bronchodilator)
Exclusion Criteria (Healthy Participants):
- Clinically significant medical history
- Acute illness within 4 weeks of screening
- Current smoker or nicotine user
- History of alcohol abuse (within prior 12 months) or drug/chemical abuse
Exclusion Criteria (NCFB Patients with P. aeruginosa):
- Primary asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)
- More than 2 pulmonary exacerbations requiring IV antibiotics within 12 months prior to screening
- Receipt of antibiotics (excluding macrolides) within 30 days prior to screening
- Clinically significant hemoptysis requiring intervention within 30 days prior to screening
- Receiving anti-infective treatment for concurrent nontuberculosis mycobacteria (NTM) or fungal infection
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cohort 1a
3.5 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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实验性的：Cohort 2a
7 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
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实验性的：Cohort 3a
14 mg Rev-56 or placebo single dose
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
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实验性的：Cohort 4a
28 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
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实验性的：Optional Cohort 5a
≤56 mg Rev-56 or placebo single dose
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
实验性的：Cohort 1b
≤28 mg Rev-56 or placebo once daily for 7 days
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
实验性的：Cohort 2b
≤28 mg Rev-56 or placebo twice daily for 7 days
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incidence and severity of treatment-emergent adverse events (AEs)
大体时间：21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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Number of participants with clinically significant abnormalities in lab parameters, vital signs, respiratory function, and ECG parameters graded by FDA Toxicity Grading Scale (for healthy participants) and DAIDS Toxicity Tables (for NCFB patients)
大体时间：21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Maximum observed concentration (Cmax) of Rev-56
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
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Time to Cmax of Rev-56 (Tmax)
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
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Area under the curve from time 0 to last measurable concentration (AUC0-last)
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Area under the curve from time 0 to 24 hours after completion of dosing (AUC0-24)
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Area under the curve from time 0 to infinity (AUC0-inf)
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Clearance of Rev-56 (CL/F)
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
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Half-life of Rev-56 (t½)
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Volume of distribution of Rev-56 (Vz/F)
大体时间：Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Minimum observed concentration of Rev-56 (Cmin)
大体时间：NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
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Mean P. aeruginosa burden (CFU/mL) in sputum culture compared to baseline
大体时间：28 days (NCFB patients with P. aeruginosa)
|
28 days (NCFB patients with P. aeruginosa)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月13日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年7月2日
首先提交符合 QC 标准的
2026年7月13日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月28日
上次提交的符合 QC 标准的更新
2026年7月27日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.