NCT03236233已完成1 期
A Randomised, Single-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety and Tolerability of Single and Repeat, Inhaled Doses of PC786 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 PC786 in Subjects With Mild Asthma
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
- 39
- 试验地点
- 1
- 主要终点
- Number of participants reporting one or more treatment-emergent adverse events (TEAE)
研究概览
简要总结
This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 & 4)
- •Must be 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 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 contraception from the time of the first dose, until 90 days after receipt of the final dose of study medication.
- •Females must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urinary pregnancy test at Day -
- •Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
- •Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and that they are willing to participate.
- •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 at screening and pre-dose.
- •Healthy Subjects (Cohorts 1, 2 & 3)
- •Healthy as determined by a physician based on a full medical examination including medical history, physical examination and laboratory tests performed at screening and pre-dose.
- •Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value and FEV1/FVC ratio > 0.7 at screening
- •Subjects with Asthma (Cohort 4)
- •Documented diagnosis of asthma, first diagnosed at least 12 months prior to the screening visit.
- •Subject must demonstrate a PC20 methacholine ≤ 8 mg/mL at the screening visit.
- •Have an FEV1 >60% of predicted normal value at least 6 h after the last use of a short acting β-agonist (SABA).
- •Have stable asthma based on physician assessment at screening and prior to randomisation
- •Subject must be otherwise healthy on the basis of a full medical examination including medical history, physical examination and laboratory tests performed at screening.
排除标准
- •All subjects (Cohorts 1, 2, 3 & 4)
- •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
- •Are taking over the counter medications other than vitamins or multivitamins and herbal medication, within 14 days prior to Screening
- •History of regular alcohol consumption within 6 months of the study of an average weekly intake of >21 units for males, or >14 units for females
- •Definite or suspected history of drug or alcohol abuse within the previous 5 years.
- •A smoker (regular or irregular), or has smoked or used nicotine-containing products (including e-cigarettes) within the 6 months prior to screening
- •A positive test for HIV-1 & -2 antibodies at screening.
- •A 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 pre-dose
- •Received an experimental drug or used an experimental medical device within 3 months before the first dose of the study drug is scheduled.
- •Allergy to any of the active or inactive ingredients in the study medication.
- •History of drug, or other allergy that would contraindicate participation.
- •Donation of blood in excess of 500 mL within a 3 month period prior to dosing
- •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
- •Pregnant or lactating female
- •Any other reason that the Investigator considers makes the subject unsuitable to participate.
- •Healthy Subjects (Cohorts 1, 2 & 3)
- •Any chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG
- •Subjects with Asthma (Cohort 4)
- •Has ever had an episode of life-threatening asthma defined as respiratory arrest, intubation for asthma, or ICU admission for asthma.
- •Presence of clinically significant diseases other than asthma, hyper-responsive airways, seasonal allergic rhinitis or atopic diseases
- •Has 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.
- •Has 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
Repeat dose - healthy subjects
Experimental
干预措施: Placebo - Repeat doses (Drug)
Single dose - subjects with asthma
Experimental
干预措施: Placebo - Single doses (Drug)
Single dose - subjects with asthma
Experimental
干预措施: PC786 - Single doses (Drug)
Single dose - healthy subjects
Experimental
干预措施: PC786 - Single doses (Drug)
Single dose - healthy subjects
Experimental
干预措施: Placebo - Single doses (Drug)
Repeat dose - healthy subjects
Experimental
干预措施: PC786 - Repeat doses (Drug)
结局指标
主要结局
Number of participants reporting one or more treatment-emergent adverse events (TEAE)
时间窗: Baseline up to Week 12
Number of participants who discontinue due to an adverse event (AE)
时间窗: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety 12-lead ECG assessment at least once post dose
时间窗: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for vital signs assessment at least once post dose
时间窗: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once once post dose
时间窗: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety spirometry assessment (FEV1 & FVC - measured together) at least once once post dose
时间窗: Baseline up to Week 12
次要结局
- Plasma concentration of PC786(Day 1: Pre-dose and at multiple time points (up to 10 days) post final dose)
- Mucosal lining fluid concentration of PC786(Cohort 1 - Day 1 = 3 samples; Day 2 = 2 samples; Day 3 = 1 sample. Cohorts 2 & 3 - Day 1 = 2 samples; Day 6 = 1 sample; Day 7 = 3 samples; Day 8 = 2 samples; Days 9 & 10 - 1 sample)
研究者
研究点 (1)
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