A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354
Condition: Asthma; Healthy
MeSH terms: Asthma
Intervention: CAT-354 150 mg (intravenous); CAT-354 150 mg (subcutaneous); CAT-354 300 mg (subcutaneous)
Intervention description: A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.; A single dose of CAT-354 150 mg injection subcutaneously on Day 0.; A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; CAT-354; Tralokinumab; Healthy

Summary:

      To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous
      administration compared with intravenous administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated written informed consent is obtained prior to any study related
             procedure taking place

          -  Males, aged 19-55 years

          -  No significant abnormality on clinical examination or medical history (excluding
             atopic skin signs, symptoms and history)

          -  A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)

          -  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 mass index (BMI) between 18-30 kilogram per square meter (kg/m^2), inclusive

          -  No other clinically significant abnormality on history and clinical examination

          -  Able to comply with the requirements of the protocol.

        Exclusion Criteria:

          -  Any active concomitant disease including psychological disorders

          -  History of medication that might carry over effects into study

          -  Previously received monoclonal antibody, or a similar related protein, that might
             sensitize subjects to CAT-354

          -  Participation in another investigational medicinal product study within 3 months of
             the start of this study or 5 half-lives of the previously administered investigational
             medicinal product (IMP), whichever is the longer except methodological studies in
             which no IMP was given

          -  Any acute illness in the 2 weeks before Day 0 (Visit 2)

          -  Any blood donation or significant loss of blood within 56 days of study initiation or
             plasma donation within 7 days of study initiation

          -  Subject is a participating Investigator, sub-Investigator, study coordinator, or
             employee of a participating Investigator, or is a first degree relative of the
             aforementioned

          -  Any factor which, in the opinion of the Investigator, would jeopardize the evaluation
             or safety or be associated with poor adherence to the protocol

          -  The subject's primary care physician recommends the subject should not take part in
             the study

          -  Subjects with immunodeficiency disorders

          -  Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis
             C or human immunodeficiency virus (HIV).