A Randomised, Single-blind, Placebo-controlled, Study to Assess the Safety and Tolerability of Single Escalating and Repeat, Inhaled Doses of PC945 in Healthy Subjects Combined With a Randomised, Single-blind, Placebo-controlled, Parallel Group to Assess the Safety and Tolerability of a Single Dose of Inhaled PC945 in Subjects With Mild Asthma

Pulmocide Ltd1 个研究点分布在 1 个国家目标入组 29 人开始时间: 2017年10月23日最近更新: 2018年5月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Pulmocide Ltd
入组人数: 29
试验地点: 1
主要终点: Incidence of treatment emergent adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

PC945 is a new medicine being developed for treatment of fungal lung diseases. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of PC945

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Single (Participant)

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

•All subjects (Cohorts 1, 2 & 3)
•Male or female, aged between 18 and 65 years inclusive (at the time of consent) who fit one of the following criteria: Women of childbearing potential who are willing and able to use required contraception from screening until 30 days after receipt of the final dose; Women of non-childbearing potential defined as being amenorrhoeic or have been permanently sterilised; Men who are willing and able to use required contraception from the time of the first dose, until 90 days after receipt of the final dose of study medication.
•Females with a negative pregnancy test at screening and at Day -
•Willing and able to adhere to the restrictions and prohibitions required by this protocol.
•Signed informed consent form.
•Body weight ≥ 50 kg and body mass index (BMI) within the range 18 - 30 kg/m2 (inclusive).
•Average QTcF <450 msec at screening and pre-dose.
•Vital signs assessments within normal ranges
•Healthy Subjects (Cohorts 1 and 2)
•Healthy as determined by a physician based on a full medical examination.
•Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value and FEV1/FVC ratio > 0.7 at screening.
•Subjects with Asthma (Cohort 3)
•Diagnosis of asthma.
•Positive result to methacholine challenge at the screening visit.
•FEV1 >60% of predicted normal value at screening.
•Stable asthma based on physician assessment at screening, with no changes of therapy in the 12 weeks prior to screening and no hospitalization or visit to accident and emergency for asthma in the 12 months prior to screening
•Otherwise healthy on the basis of a full medical examination at screening

排除标准

•All subjects (Cohorts 1, 2 & 3)
•Any acute illness.
•Upper or lower respiratory tract infection within 4 weeks of the screening visit or randomisation.
•Use of prescription medications within 14 days of the Screening visit.
•Taking over the counter (OTC) medications other than vitamins or multivitamins, within 14 days prior to Screening.
•History of regular alcohol consumption within 6 months of the study with average weekly intake of >21 units for males, or >14 units for females.
•History of drug or alcohol abuse within the previous 5 years.
•Smoker (regular or irregular), or has smoked or used nicotine-containing products (including e-cigarettes) within the 6 months prior to screening or has a smoking history of ≥ 10 pack years.
•Positive test for HIV-1 & -2 antibodies at screening.
•Positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.
•Positive test for alcohol, smoking or drugs of abuse at screening or Day -
•Received an experimental drug or used an experimental medical device within last 3 months.
•Allergy to any of the active or inactive ingredients in the study medication.
•Donation of blood in excess of 500 mL within a 3 month period prior to dosing, or if study participation would result in blood loss in excess of 500 mL in a 3 month period.
•Mentally or legally incapacitated.
•An employee of the Sponsor or contract research organisation (CRO), or a relative of an employee of the Sponsor or CRO.
•Unable or unwilling to undergo multiple venepuncture procedures or poor access to veins suitable for cannulation.
•Pregnant or lactating female
•Healthy subjects (Cohorts 1 and 2)
•Any chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG.
•Subjects with asthma (Cohort 3)
•Had an episode of life-threatening asthma.
•Presence of clinically significant diseases other than asthma, hyper-responsive airways, seasonal allergic rhinitis or atopic diseases.
•Experienced an acute asthma exacerbation in the 12 months prior to screening requiring hospitalisation or accident and emergency treatment or management with systemic or injectable steroids.
•Uncontrolled, or moderate to severe asthma based on PI assessment and/or use of prohibited medications, or has required treatment with these therapies in the previous 12 weeks.
•History or presence of any known conditions contraindicated for methacholine challenge.

研究组 & 干预措施

Single dose - healthy volunteers

Experimental

干预措施: PC945 - single doses (Drug)

Single dose - healthy volunteers

Experimental

干预措施: Placebo - single doses (Drug)

Repeat dose - healthy volunteers

Experimental

干预措施: PC945 - repeat doses (Drug)

Repeat dose - healthy volunteers

Experimental

干预措施: Placebo - repeat doses (Drug)

Single dose - asthmatic patients

Experimental

干预措施: PC945 - single doses (Drug)

Single dose - asthmatic patients

Experimental

干预措施: Placebo - single doses (Drug)