Status:
COMPLETED
A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786
Lead Sponsor:
Pulmocide Ltd
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03236233
Start Date
June 21 2017
End Date
December 15 2017
Last Update
December 21 2017
Active Locations (1)
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1
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW