A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma
Condition: Moderate Asthma
MeSH terms: Asthma
Intervention: CAT-354 1mg/kg; CAT-354 5 mg/kg; CAT-354 10mg/kg; Placebo
Intervention description: CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.; CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.; CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.; Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Asthma; CAT-354; Tralokinumab

Summary:

      The study includes participants with moderate asthma who were randomly assigned to receive
      the study medication (CAT-354) or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or infertile females

          -  Subjects with asthma, well controlled on inhaled corticosteroid and taken as required
             (PRN) short acting beta 2 agonist therapy only

          -  Unchanged dose of inhaled corticosteroid for 3 months prior to Day 0 and no expected
             need for change in dose during study

          -  Forced expiratory volume in 1 second (FEV1) greater than or equal to 80% predicted at
             Screening (Baseline)

          -  18-60 years

          -  General Practitioner diagnosis of asthma of 1 year's minimum duration (with respect to
             Day 0)

          -  No significant abnormality on clinical examination or medical history (excluding
             atopic skin signs, symptoms and history)

          -  12-lead electrocardiogram with no clinical significant abnormality

          -  Clinical chemistry hematology and urinalysis results within the laboratory reference
             ranges or deemed not clinically significant by the Investigator

          -  A negative screen for drugs of abuse and alcohol

          -  Body weight between 50-120 kg

          -  Subjects aged between 18-40 years inclusive must have body mass index (BMI) 18-32
             kilogram per square meter (kg/m^2) inclusive. Subjects aged between 41-60 years must
             have BMI between 18-30 kg/m^2 inclusive.

        Exclusion Criteria:

          -  Active concomitant disease, with exception of eczema

          -  Expected onset of seasonal allergy before the administration of the last dose of study
             medication

          -  History of severe exacerbation within 3 years of Day 0

          -  Recorded use of inhaled short acting beta 2 agonist medication for symptoms within 14
             days of Day 0 of: More than 6 doses per day on any 1 day or more than 3 doses per day
             on 6 or more days

          -  Any medication other than: inhaled short-acting beta 2 agonist, inhaled
             corticosteroids, topic eczema treatments (with the exception of fluorinated
             corticosteroid, dermatological preparations which are not permitted), hormone
             replacement therapy, vitamin preparation/food supplements, occasional use of proton
             pump inhibitors, ranitidine, cimetidine, antacids or over-the-counter analgesics

          -  Treatment within 6 months of Day 0 with any of the following: methylxanthines, inhaled
             cromones, leukotriene modifiers, anti- immunoglobulin E (IgE), anticholinergics,
             ketotifen, oral short acting B2 agonists, long-acting B2 agonists, oral or injected
             corticosteroids

          -  Treatment of atopic symptoms, other than eczema, within 4 weeks of Day 0

          -  History of medication that might carry-over effects into the study

          -  Previously received monoclonal antibody, or a similar related protein, that might
             sensitize to CAT-354

          -  Participation in another study within three months of the start of the study or 5 half
             lives of the previously administered investigational medicinal product (IMP),
             whichever is longer

          -  Lower respiratory tract infection within 4 weeks of Day-14

          -  Any acute illness in the two weeks before Day 0

          -  Current smokers, those who have smoked in previous year, and those with smoking
             history of greater than or equal to 10 pack years

          -  Considered by the investigator to be at risk of transmitting, through blood, the
             agents responsible for infectious diseases

          -  Blood donation (550 ml) in the previous 2 months

          -  Excessive intake of alcohol (more than 21 units a week for females or 28 units a week
             for males)

          -  The subject's general practitioner has suggested a reason the subject should not
             participate in the study

          -  The Investigator considers the subject should not take part for any reason.