a study to investigate the safety and tolerability of single and repeat doses of pc786

Conditions: Respiratory Syncytial Virus (RSV)

Summary: this study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of pc786.


Eligibility criteria:
inclusion criteria: 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 -1. * 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. exclusion criteria: 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