NCT06662019已完成1 期
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers.
NeoTrials Pty Ltd1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年10月29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
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
Randomized, double-blind, placebo-controlled, dose-escalation Phase I safety study of inhaled N-IP-00001, to determine tolerability and safety in healthy volunteers.
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
- 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
- •Age ≥ 18 years and ≤ 55 years.
- •Male or non-pregnant, non-lactating Female
- •Normally active and in good health as determined by the investigator or sub-investigator (who is a qualified physician)through physical examination, vital signs and laboratory parameters.
- •No current acute or chronic respiratory conditions.
- •FEV1 ≥ 80% predicted.
- •Ability to achieve reproducible FEV1 spirometry, as determined by 3 acceptable maneuvres within no more than 5 attempted maneuvres. The best two values should be within 5% or 150mL of each other, whichever is greater.
- •Ability to comply with study medication use, study visits, and study procedures as judged by the investigator.
- •Able to understand and sign an informed consent.
- •Non-smoker and has not smoked for at least 6 months.
排除标准
- •Bowel disease
- •Bariatric surgery
- •Evidence of biliary cirrhosis with portal hypertension
- •History of any drug or alcohol abuse in the past 1 year defined as >21 units of alcohol per week for males and >14 units of alcohol per week for females. Where 1 unit = 360ml of beer, 150ml of wine, or 45ml of spirits.
- •History of lung transplant.
- •History of asthma.
- •History of allergic reactions to fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut)
- •Antibiotic treatment within 4 weeks prior to screening
- •Recent (2 weeks) upper respiratory tract infection or COVID
- •Recurrent cough
- •Poor venous access
- •Unexplained, positive drugs of abuse or alcohol breath test results at the screening visit or positive alcohol breath test at check-in.
- •Not able and willing to refrain from alcohol from 24 hours before the first dose through study confinement
- •Unwilling to abstain from fermented foods (kimchi, yoghurt, kefir, kombucha, sauerkraut) and strenuous exercise for 24 hours prior to dosing. Unwilling to abstain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) during confinement at the clinical unit'.
- •Participants who have received any investigational drug in a clinical research study within the previous 30 days prior to screening or 5 half-lives, whichever is longer.
- •Failure to satisfy the investigator of fitness to participate for any other reason.
- •Currently taking any medication by the inhaled route.
- •Those with commercial interest in the product or related products.
研究组 & 干预措施
Dosing arm
Experimental
干预措施: N-IP-00001 inhalation solution (Drug)
Control
Placebo Comparator
Nebulized treatment consisting of 0.9% saline solution.
干预措施: 0.9% NaCl isotonic saline solution (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 2 weeks
FEV1 measured by spirometry
时间窗: Up to 2 weeks
Changes in vital signs
时间窗: Up to 2 weeks
Changes in blood pressure, temperature, pulseoximetry, and heart rate.
次要结局
未报告次要终点
研究者
研究点 (1)
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