Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants
Condition: Healthy Volunteers
Intervention: Placebo; GSK2330811
Intervention description: Placebo is 0.9 percent sodium chloride solution. It will be administered as SC injection to abdomen by study personnel. Three injections will be used to match active doses.; GSK2330811 will be available as SC injection 150 mg/mL.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel group study. Participants will be randomized to receive either GSK2330811 (450 mg) or placebo in an approximate ratio of 7:3.
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK2330811; Healthy participants; Japanese; Pharmacokinetics; Safety; Subcutaneous dose

Summary:

      This is a randomized, double-blind (sponsor-open), placebo-controlled, single-center study
      involving Japanese participants. The purpose of the study is to assess the safety,
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity after a single
      subcutaneous (SC) dose of GSK2330811 in healthy Japanese participants. GSK2330811 is a
      humanized immunoglobulin G1 (IgG1) monoclonal antibody that binds and inhibits the action of
      Oncostatin M (OSM) and is being developed for the treatment of Crohn's disease (CD) and
      Systemic sclerosis (SSc). Participants will be randomized to receive either GSK2330811 (450
      milligram [mg]) or placebo in an approximate ratio of 7:3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 18 to 65 years of age inclusive, at the time of signing the
             informed consent.

          -  Participants who are overtly healthy as determined by medical evaluation including
             medical history, physical examination, laboratory tests and 12-lead ECGs.

          -  A participant with a clinical abnormality or laboratory parameters outside the
             reference range for the healthy population being studied that is not specifically
             listed in the inclusion or exclusion criteria may be included if the investigator and
             sponsor medical monitor agree and document that the finding is unlikely to introduce
             additional risk factors and will not interfere with the study procedures or
             interpretation.

          -  Participants with body weight >=45 kilogram (kg) and body mass index (BMI) within the
             range 18.5-29.9 kg per square meter.

          -  Male participants.

          -  Participants capable of giving signed informed consent which includes compliance with
             the requirements and restrictions listed in the informed consent form (ICF) and in
             this protocol.

          -  Participants with Japanese ancestry, defined as having been born in Japan, being
             descendants of four ethnic Japanese grandparents and two ethnic Japanese parents,
             holding a Japanese passport or identity papers, and being able to speak Japanese.
             Participants should have lived outside Japan for less than 10 years at the time of
             screening.

        Exclusion Criteria:

          -  Participants with sensitivity to any of the study treatments or components there of
             (including humanized monoclonal antibodies) or history of severe post treatment
             hypersensitivity reactions including erythema multiforme major, linear immunoglobulin
             A (IgA) dermatosis, toxic epidermal necrolysis and exfoliative dermatitis.

          -  Participants with any other history of significant allergy that in the opinion of the
             investigator contraindicates their participation in this study.

          -  Participants with an active infection or a history of serious infections as follows:
             Use of antimicrobials (antibacterials, antivirals, antifungals or antiparasitic
             agents) for an infection within 30 days prior to Day 1. Topical treatments may be
             allowed at the Investigator's discretion (in consultation with the Medical Monitor); A
             history of opportunistic or recurrent infections, as determined by the investigator;
             Currently active or unresolved infection (participants with 'trivial' infections such
             as tinea pedis may be eligible at the discretion of the investigator); Symptomatic
             herpes zoster within 3 months prior to screening; History of tuberculosis (TB) (active
             or latent) irrespective of treatment status; and a positive diagnostic TB test at
             screening (defined as a positive QuantiFERON test).

          -  Participants with any planned major surgical procedure during the study.

          -  Participants with a history of hematological disease, for example (but not limited
             to): significant anemia, platelet disorders including drug-induced thrombocytopenia or
             primary immune thrombocytopenia and coagulation disorders including von Willebrand's
             disease.

          -  Participants with a history of carcinoma in situ and malignant disease, with the
             exception of adequately treated non-metastatic basal or squamous cell cancer of the
             skin that has been fully treated and shows no evidence of recurrence after 3 years.

          -  Participants with QTc >450 millisecond (msec) at screening.

          -  Participants with use of prescription or non-prescription drugs (including
             recreational drugs and herbal medications) within 7 days or 5 half-lives (whichever is
             longer) prior to Day 1 unless in the opinion of the investigator (in consultation with
             the sponsor medical monitor) the medication will not interfere with the study or
             compromise participant safety. Paracetamol at doses of <=4 grams per day, and
             occasional use of non-steroidal anti-inflammatory drugs (NSAIDs) at licensed doses,
             are permitted.

          -  Participants who received live vaccination within 4 weeks prior to Day 1, or any plan
             to receive a live vaccination during the study (up to and including to the last
             follow-up visit).

          -  Participation in a clinical trial and has received an investigational medicine product
             (IMP) within the following time period prior to Day 1: 3 months, 5 half-lives, or
             twice the duration of the biological effect of the IMP (whichever is longer).

          -  Participants with exposure to more than 4 new chemical entities within 12 months prior
             to Day 1.

          -  Participation in the study would result in loss of blood or blood products in excess
             of 500 milliliter (mL) within 3 months.

          -  Participants with platelet count or hemoglobin below the normal range at any time
             during screening.

          -  Participants with alanine aminotransaminase (ALT) >1.5 times upper limit of normal
             (ULN) at any time during screening.

          -  Participants with bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is
             acceptable if bilirubin is fractionated and direct bilirubin <35 percent) at any time
             during screening.

          -  Participants with presence of hepatitis B surface antigen (HBsAg) or hepatitis B core
             antibody (HBcAb), or positive hepatitis C virus (HCV) antibody result at screening.
             Participants with positive HCV antibody due to prior resolved disease can be enrolled
             only if a confirmatory negative HCV Ribonucleic acid (RNA) test is obtained.

          -  Participants with positive human immunodeficiency virus (HIV) antibody test at
             screening.

          -  Participants with positive pre-study drug or alcohol screen.

          -  Participants with history of regular alcohol consumption within 6 months of the
             screening visit in excess of an average weekly intake of >21 units. One unit is
             equivalent to 8 gram of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass
             (125 mL) of wine or 1 (25 mL) measure of spirits.

          -  Participants planning to travel to regions of high endemic infection, as determined by
             the investigator, for the duration of the study.

          -  Participants with unstable lifestyle factors, to the extent that in the opinion of the
             investigator they would interfere with the ability of a participant to complete the
             study.