Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab for IV; Belimumab for SC
Intervention description: Belimumab will be available as white to off-white lyophilized cake at a unit dose strength of 400 mg to be reconstituted and diluted in normal saline to obtain 200 mg per dose.; Belimumab will be available as clear to opalescent, colorless to pale yellow sterile solution at unit dose strength of 200 mg/milliliter (mg/mL) for SC injection in a single-use, prefilled syringe contained within an auto-injector device.
Intervention MeSH terms: Belimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:2 ratio to receive one treatment of either IV or SC administration of belimumab 200 mg.
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: belimumab; Chinese; intravenous; subcutaneous; auto-injector

Summary:

      This is an open-label, randomized, parallel group, single dose study in healthy Chinese
      subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety
      profile of 200 mg single dose of belimumab, administered either intravenously or
      subcutaneously via auto-injector. Each subject will be randomized in a 1:2 ratio to receive a
      single dose of either intravenous (IV) or subcutaneous (SC) administration of belimumab 200
      mg. The total study duration will be approximately 13 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and protocol.

          -  Chinese healthy male or female between 18 and 45 years of age inclusive, at the time
             of signing the informed consent.

          -  Healthy as defined as being free from clinically significant illness or disease as
             determined by a responsible and experienced physician, based on a medical evaluation
             including medical history, physical examination, vital sign, laboratory tests and ECG.
             A subject with a clinical abnormality or laboratory parameter(s) which is/are not
             specifically listed in the inclusion or exclusion criteria, outside the reference
             range for the population being studied, may be included only if the investigator (in
             consultation with the GlaxoSmithKline (GSK) medical monitor if necessary) agree and
             document that the finding is unlikely to introduce additional risk factors and will
             not interfere with the study procedures.

          -  Non-smoker or ex-smoker having ceased smoking for at least 6 months.

          -  Body weight >=45.0 kilograms (kg) for females, >=50.0 kg for males, and body mass
             index (BMI) within the range 19.0<= to <=26.0 kilograms per meter square (kg/m^2).

          -  Both male and female subjects are eligible to participate.

          -  A female subject is eligible to participate if she is not pregnant, not breastfeeding,
             and at least one of the following conditions applies: i) Not a woman of childbearing
             potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance
             during the treatment period and for at least 16 weeks after the last dose of
             belimumab.

        Exclusion Criteria:

          -  A positive test for syphilis, positive Hepatitis C antibody, human immune deficiency
             syndrome (HIV) antigen/antibody, at Screening. For Hepatitis B: subjects with a
             positive hepatitis B surface antigen (HbsAg) and/or a positive anti-hepatitis B core
             (HBc) result will be excluded.

          -  A positive result of pre-study drug screen (including at minimum: amphetamines,
             barbiturates, cocaine, opiates, cannabinoids and benzodiazepines).

          -  ALT or AST >1.2 times upper limit of normal (ULN).

          -  Bilirubin >1.2 times ULN (isolated bilirubin >1.2 times ULN is acceptable if bilirubin
             is fractionated and direct bilirubin <35%).

          -  QTc >450 milliseconds (msec) based on single ECG. The QTc is the QT interval corrected
             for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF),
             and/or another method, machine read or manually over-read.

          -  Immunoglobulin (M, A, G) level is <Lower limit of normal (LLN) at Screening.

          -  Current or chronic history of liver disease or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  History of major organ transplant: e.g., heart, lung, kidney, liver, or hematopoietic
             stem cell transplant.

          -  History of malignant neoplasm within the last 5 years, except for adequately treated
             basal or squamous cell cancers of the skin, or carcinoma in situ of the uterine
             cervix.

          -  Subjects with a sitting position systolic blood pressure <90 millimeters of mercury
             (mmHg) or >=140 mmHg and/or a sitting diastolic blood pressure <50 mmHg or >=90 mmHg
             and/or systolic blood pressure drop from supine to standing of >30 mmHg.

          -  Symptomatic herpes zoster within 3 months prior to Screening.

          -  Evidence of active or latent tuberculosis (TB) as documented by medical history and
             examination, chest X-rays (posteroanterior) and a positive (not indeterminate)
             QuantiFERON-TB Gold test.

          -  History of any infection requiring hospitalization or treatment with antivirals,
             antibiotics, anti-fungals, anti-parasitic agents or vaccination within 30 days prior
             to the administration of study medication.

          -  History of regular alcohol consumption exceeding, on an average, 14 drinks/week for
             men or 7 drinks/week for female (1 drink = 5 ounces [150 mL] of wine or 350 mL of beer
             or 1.5 ounces [45 mL] of 80 proof distilled spirits) within 6 months of Screening.

          -  The subject had participated in a clinical study or post-marketing study with an
             investigational or a non-investigational product during the previous 4 months or 5
             half-lives (whichever is longer) preceding the administration of study medication of
             this study.

          -  Exposure to more than 4 new chemical entities within 12 months prior to the dosing
             day.

          -  The subject planned to concurrently participate in another clinical study or post
             marketing study.

          -  Use of any prescription or non-prescription medications including vitamins, herbal and
             dietary supplements within the 14 days or 5 half-lives (whichever is longer) prior to
             the administration of study medication.

          -  History of B cell targeted therapy (rituximab, other anti-cluster of differentiation
             (CD)20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], B lymphocyte
             stimulator (BlyS)-receptor fusion protein [BR3], Transmembrane activator and
             calcium-modulator and cytophilin ligand interactor (TACI)-fusion (Fc), LY2127399
             [anti-B cell-activating factor receptor (BAFF)] or belimumab) at any time.

          -  Have received a live vaccine within 30 days of Day 1 or anticipate receipt of a live
             vaccine during the study or within 120 days after the last dose administration of
             study drug.

          -  History of sensitivity to any of the study medications, or components thereof or a
             history of drug or other allergy (excluding pollen allergy) without current symptoms.

          -  History of anaphylactic reaction to any food, drug, or insect bite/sting.

          -  History of allergic reaction to parenteral administration of contrast agents, foreign
             proteins, or monoclonal antibodies.

          -  Donation of blood or blood products or significant blood loss in excess of 400 mL
             within 4 months or 200 mL within 2 months prior to administration

          -  Subject is mentally or legally incapacitated, or unwillingness or inability (including
             mentally or legally incapacity) to follow the procedures outlined in the protocol.