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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04136145
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 14

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Belimumab for IV; Drug: Belimumab for SC	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• 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.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)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Participants
• Actual Study Start Date: Oct 28, 2019
• Actual Primary Completion Date: Jan 14, 2020
• Actual Study Completion Date: Jan 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belimumab SC Subjects will be administered a single dose of belimumab 200 mg via the SC route. The dose will be administered in the front of the thigh via auto-injector device.	Drug: Belimumab for SC; 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.
Experimental: Belimumab IV Subjects will be administered a single dose of belimumab 200 mg via the IV route administered over approximately 1 hour.	Drug: Belimumab for IV; 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.

Outcome Measures

Primary Outcome Measures

1. Serum Concentration of Belimumab Following Intravenous Administration [Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion]

   Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following intravenous administration. Pharmacokinetic Population comprised of all safety participants (all randomized participants who received at least one dose of study treatment) for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.

2. Serum Concentration of Belimumab Following Subcutaneous Administration [Pre-dose and at 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 240 hours, 336 hours, 504 hours, 672 hours, 1008 hours, 1344 hours and 1680 hours post-dose]

   Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following subcutaneous administration.

Secondary Outcome Measures

1. Number of Participants With Abnormal Vital Signs [Up to Day 71]

   Vital signs were measured in a semi-supine position after five minutes of rest and included tympanic temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The normal ranges were: temperature (35.0-38.0 degrees celsius), SBP (85-160 millimeters of mercury [mmHg]), DBP (45-100 mmHg), heart rate (60-90 beats per minute). Number of participants with abnormality in any vital signs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.

2. Number of Participants With Abnormal Electrocardiogram (ECG) Findings [Up to Day 71]

   Twelve-lead ECGs were recorded with the participants in a semi-supine position, after 5 minutes of rest using an ECG machine. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with clinically significant and not clinically significant abnormal ECG findings have been presented.

3. Number of Participants With Abnormal Clinical Chemistry Parameters [Up to Day 71]

   Blood samples were collected for the assessment of clinical chemistry parameters. The normal ranges were: alanine aminotransferase(7-40 international units per liter[IU/L]), albumin(40-55 grams per liter[g/L]), alkaline phosphatase(35-100 IU/L), amylase(25-125 units per liter), aspartate aminotransferase(13-35 IU/L), bilirubin(Bil.)(3.4-20.5 micromoles per liter [µmol/L]), calcium(2.1-2.55 millimoles per liter[mmol/L]), chloride(99-110 mmol/L), cholesterol(Chol.)(0-5.17 mmol/L), creatine kinase(29-168 IU/L), creatinine(41-73 µmol/L), direct Bil.(0-8.6 µmol/L), gamma glutamyl transferase(7-45 IU/L), glucose(3.9-6.1 mmol/L), high density Chol.(1.04-1.55 mmol/L), low density Chol.(2.59-4.11 mmol/L), lactate dehydrogenase(120-250 IU/L), phosphate(0.74-1.52 mmol/L), potassium(3.5-5.3 mmol/L), protein(65-85 g/L), sodium(137-147 mmol/L), triglycerides(0-1.69 mmol/L), urate(150-350 µmol/L), urea(2.6-7.5 mmol/L). Number of participants with abnormal clinical chemistry parameters are presented.

4. Number of Participants With Abnormal Hematology Parameters [Up to Day 71]

   Blood samples were collected for the assessment of hematology parameters. The normal ranges for the parameters were: basophil count ([0.00-0.06]*10^9 cells per liter [cells/L]), eosinophil count ([0.02-0.52]*10^9 cells/L), erythrocyte count ([3.8-5.1]*10^12 cells/L), hematocrit (0.35-0.45 proportion of red blood cells in blood), hemoglobin (115-150 g/L), leukocyte count ([3.5-9.5]*10^9 cells/L), lymphocyte count ([1.1-3.2]*10^9 cells/L), monocyte count ([0.1-0.6]*10^9 cells/L), neutrophil count ([1.8-6.3]*10^9 cells/L), platelet count ([125-350]*10^9 cells/L). Number of participants with abnormal hematology parameters are presented.

5. Number of Participants With Abnormal Urinalysis Parameters [Up to Day 71]

   Urine samples were analyzed for glucose, ketones, occult blood and protein by dipstick method. The dipstick test results are read as Negative, Trace, 1+, 2+, 3+, 4+ indicating proportional concentrations in the urine sample. Normal range for dipstick test results are 'negative' results. Urine potential of hydrogen (pH) and specific gravity were also analyzed. pH is measured on a numeric scale of 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Urine specific gravity is a measure of the concentration of solutes in the urine and indicated as ratio of urine density to water density. The normal ranges for pH: 4.8 to 7.4; and for specific gravity: 1.003 to 1.03. Number of participants with abnormal results in any urinalysis parameters are presented.

6. Number of Participants With Injection Site Reaction [Up to Day 71]

   Local tolerability as measured by injection site reaction example: induration, erythema, edema, rash, pruritis or pain. Number of participants with any injection site reaction are presented.

7. Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events [Up to Day 71]

   An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Shanghai		China	201508

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Jun 27, 2019
• Statistical Analysis Plan - Feb 27, 2020

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04136145
• Other Study ID Numbers: 209629
• First Posted: Oct 23, 2019
• Last Update Posted: Dec 28, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: belimumab; Chinese; intravenous; subcutaneous; auto-injector
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Belimumab

Study Results

Participant Flow

Recruitment Details	This was an open-label, randomized, parallel group, single dose study to evaluate safety and pharmacokinetics (PK) of belimumab, administered either intravenously (IV) or subcutaneously (SC) via an auto-injector in healthy Chinese participants.
Pre-assignment Detail	A total of 171 participants were screened and 36 participants were enrolled and randomized in the study.

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Period Title: Overall Study
STARTED	12	24
COMPLETED	12	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC	Total
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.	Total of all reporting groups
Overall Participants	12	24	36
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	27.9 (3.99)	29.1 (6.44)	28.7 (5.71)
Sex: Female, Male (Count of Participants)
Female	3 25%	4 16.7%	7 19.4%
Male	9 75%	20 83.3%	29 80.6%
Race/Ethnicity, Customized (Count of Participants)
Asian - East Asian Heritage	12 100%	24 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Serum Concentration of Belimumab Following Intravenous Administration
Description	Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following intravenous administration. Pharmacokinetic Population comprised of all safety participants (all randomized participants who received at least one dose of study treatment) for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.
Time Frame	Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Belimumab 200 mg IV
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.
Measure Participants	12
Pre-dose (prior to start of belimumab IV infusion)	0.0 (0.00)
30 minutes (after the start of infusion)	26567.4 (3602.68)
0 hour (end of infusion)	63403.2 (6104.64)
1hour after end of infusion	64474.6 (9167.16)
6 hours after end of infusion	57450.1 (7804.49)
24 hours after end of infusion	50284.8 (4898.92)
48 hours after end of infusion	40738.2 (6858.36)
72 hours after end of infusion	32845.9 (9835.93)
96 hours after end of infusion	30995.0 (6472.10)
168 hours after end of infusion	23850.3 (3898.42)
336 hours after end of infusion	15930.7 (3859.50)
504 hours after end of infusion	11291.5 (3860.41)
672 hours after end of infusion	10115.7 (2289.97)
1008 hours after end of infusion	5838.3 (1868.93)
1344 hours after end of infusion	3146.7 (1275.16)
1680 hours after end of infusion	1916.6 (936.49)

2. Primary Outcome

Title	Serum Concentration of Belimumab Following Subcutaneous Administration
Description	Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following subcutaneous administration.
Time Frame	Pre-dose and at 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 240 hours, 336 hours, 504 hours, 672 hours, 1008 hours, 1344 hours and 1680 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	24
Pre-dose	0.0 (0.00)
6 hours post-dose	963.8 (875.47)
24 hours post-dose	6255.4 (4255.21)
48 hours post-dose	11838.9 (5838.53)
72 hours post-dose	14501.9 (6105.54)
96 hours post-dose	16682.3 (6038.30)
120 hours post-dose	16131.3 (6055.17)
144 hours post-dose	16752.1 (5184.15)
168 hours post-dose	16825.5 (5095.95)
240 hours post-dose	17262.9 (3702.00)
336 hours post-dose	14724.2 (3519.94)
504 hours post-dose	11235.9 (2928.08)
672 hours post-dose	7551.1 (2836.06)
1008 hours post-dose	4720.3 (1827.40)
1344 hours post-dose	2651.6 (1345.36)
1680 hours post-dose	1365.7 (931.47)

3. Secondary Outcome

Title	Number of Participants With Abnormal Vital Signs
Description	Vital signs were measured in a semi-supine position after five minutes of rest and included tympanic temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The normal ranges were: temperature (35.0-38.0 degrees celsius), SBP (85-160 millimeters of mercury [mmHg]), DBP (45-100 mmHg), heart rate (60-90 beats per minute). Number of participants with abnormality in any vital signs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.
Time Frame	Up to Day 71

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	12	24
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Description	Twelve-lead ECGs were recorded with the participants in a semi-supine position, after 5 minutes of rest using an ECG machine. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with clinically significant and not clinically significant abnormal ECG findings have been presented.
Time Frame	Up to Day 71

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	12	24
Abnormal-Not Clinically significant	3 25%	7 29.2%
Abnormal-Clinically significant	0 0%	2 8.3%

5. Secondary Outcome

Title	Number of Participants With Abnormal Clinical Chemistry Parameters
Description	Blood samples were collected for the assessment of clinical chemistry parameters. The normal ranges were: alanine aminotransferase(7-40 international units per liter[IU/L]), albumin(40-55 grams per liter[g/L]), alkaline phosphatase(35-100 IU/L), amylase(25-125 units per liter), aspartate aminotransferase(13-35 IU/L), bilirubin(Bil.)(3.4-20.5 micromoles per liter [µmol/L]), calcium(2.1-2.55 millimoles per liter[mmol/L]), chloride(99-110 mmol/L), cholesterol(Chol.)(0-5.17 mmol/L), creatine kinase(29-168 IU/L), creatinine(41-73 µmol/L), direct Bil.(0-8.6 µmol/L), gamma glutamyl transferase(7-45 IU/L), glucose(3.9-6.1 mmol/L), high density Chol.(1.04-1.55 mmol/L), low density Chol.(2.59-4.11 mmol/L), lactate dehydrogenase(120-250 IU/L), phosphate(0.74-1.52 mmol/L), potassium(3.5-5.3 mmol/L), protein(65-85 g/L), sodium(137-147 mmol/L), triglycerides(0-1.69 mmol/L), urate(150-350 µmol/L), urea(2.6-7.5 mmol/L). Number of participants with abnormal clinical chemistry parameters are presented.
Time Frame	Up to Day 71

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	12	24
Count of Participants [Participants]	12 100%	24 100%

6. Secondary Outcome

Title	Number of Participants With Abnormal Hematology Parameters
Description	Blood samples were collected for the assessment of hematology parameters. The normal ranges for the parameters were: basophil count ([0.00-0.06]*10^9 cells per liter [cells/L]), eosinophil count ([0.02-0.52]*10^9 cells/L), erythrocyte count ([3.8-5.1]*10^12 cells/L), hematocrit (0.35-0.45 proportion of red blood cells in blood), hemoglobin (115-150 g/L), leukocyte count ([3.5-9.5]*10^9 cells/L), lymphocyte count ([1.1-3.2]*10^9 cells/L), monocyte count ([0.1-0.6]*10^9 cells/L), neutrophil count ([1.8-6.3]*10^9 cells/L), platelet count ([125-350]*10^9 cells/L). Number of participants with abnormal hematology parameters are presented.
Time Frame	Up to Day 71

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	12	24
Count of Participants [Participants]	10 83.3%	15 62.5%

7. Secondary Outcome

Title	Number of Participants With Abnormal Urinalysis Parameters
Description	Urine samples were analyzed for glucose, ketones, occult blood and protein by dipstick method. The dipstick test results are read as Negative, Trace, 1+, 2+, 3+, 4+ indicating proportional concentrations in the urine sample. Normal range for dipstick test results are 'negative' results. Urine potential of hydrogen (pH) and specific gravity were also analyzed. pH is measured on a numeric scale of 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Urine specific gravity is a measure of the concentration of solutes in the urine and indicated as ratio of urine density to water density. The normal ranges for pH: 4.8 to 7.4; and for specific gravity: 1.003 to 1.03. Number of participants with abnormal results in any urinalysis parameters are presented.
Time Frame	Up to Day 71

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	12	24
Count of Participants [Participants]	4 33.3%	11 45.8%

8. Secondary Outcome

Title	Number of Participants With Injection Site Reaction
Description	Local tolerability as measured by injection site reaction example: induration, erythema, edema, rash, pruritis or pain. Number of participants with any injection site reaction are presented.
Time Frame	Up to Day 71

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	12	24
Count of Participants [Participants]	0 0%	19 79.2%

9. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events
Description	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented.
Time Frame	Up to Day 71

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Belimumab 200 mg IV	Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Measure Participants	12	24
SAEs	0 0%	0 0%
Non-SAEs	11 91.7%	24 100%

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-serious adverse events were collected from the start of study treatment (Day 1) up to Day 71
Adverse Event Reporting Description	SAEs and non-serious adverse events were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study treatment.
Arm/Group Title	Belimumab 200 mg IV		Belimumab 200 mg SC
Arm/Group Description	Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.		Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
All Cause Mortality
	Belimumab 200 mg IV		Belimumab 200 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/24 (0%)
Serious Adverse Events
	Belimumab 200 mg IV		Belimumab 200 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Belimumab 200 mg IV		Belimumab 200 mg SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/12 (91.7%)		24/24 (100%)
Gastrointestinal disorders
Abdominal pain upper	0/12 (0%)		1/24 (4.2%)
Diarrhoea	2/12 (16.7%)		0/24 (0%)
Gingival bleeding	0/12 (0%)		1/24 (4.2%)
Glossodynia	0/12 (0%)		2/24 (8.3%)
Lip blister	0/12 (0%)		1/24 (4.2%)
Mouth ulceration	1/12 (8.3%)		4/24 (16.7%)
Nausea	0/12 (0%)		2/24 (8.3%)
Tongue ulceration	1/12 (8.3%)		0/24 (0%)
Toothache	0/12 (0%)		1/24 (4.2%)
General disorders
Asthenia	2/12 (16.7%)		0/24 (0%)
Fatigue	0/12 (0%)		1/24 (4.2%)
Injection site hypoaesthesia	0/12 (0%)		1/24 (4.2%)
Injection site pain	0/12 (0%)		19/24 (79.2%)
Infections and infestations
Furuncle	1/12 (8.3%)		0/24 (0%)
Gastroenteritis	1/12 (8.3%)		0/24 (0%)
Nasopharyngitis	0/12 (0%)		2/24 (8.3%)
Oral herpes	1/12 (8.3%)		0/24 (0%)
Upper respiratory tract infection	2/12 (16.7%)		3/24 (12.5%)
Vaginal infection	0/12 (0%)		1/24 (4.2%)
Injury, poisoning and procedural complications
Soft tissue injury	0/12 (0%)		1/24 (4.2%)
Investigations
Alanine aminotransferase increased	0/12 (0%)		2/24 (8.3%)
Aspartate aminotransferase increased	0/12 (0%)		1/24 (4.2%)
Bacterial test positive	2/12 (16.7%)		4/24 (16.7%)
Blood bilirubin increased	1/12 (8.3%)		1/24 (4.2%)
Blood creatinine increased	1/12 (8.3%)		0/24 (0%)
Blood glucose increased	0/12 (0%)		1/24 (4.2%)
Blood immunoglobulin M decreased	1/12 (8.3%)		3/24 (12.5%)
Blood triglycerides increased	0/12 (0%)		1/24 (4.2%)
Blood uric acid increased	2/12 (16.7%)		3/24 (12.5%)
Electrocardiogram T wave abnormal	0/12 (0%)		2/24 (8.3%)
Gamma-glutamyltransferase increased	0/12 (0%)		1/24 (4.2%)
Glomerular filtration rate decreased	1/12 (8.3%)		0/24 (0%)
Glucose urine present	0/12 (0%)		1/24 (4.2%)
Haematocrit decreased	0/12 (0%)		1/24 (4.2%)
Haemoglobin decreased	1/12 (8.3%)		2/24 (8.3%)
Heart rate increased	0/12 (0%)		1/24 (4.2%)
Neutrophil count decreased	0/12 (0%)		4/24 (16.7%)
Neutrophil count increased	1/12 (8.3%)		0/24 (0%)
Occult blood positive	0/12 (0%)		4/24 (16.7%)
Urine ketone body present	0/12 (0%)		2/24 (8.3%)
White blood cell count increased	2/12 (16.7%)		0/24 (0%)
White blood cells urine positive	1/12 (8.3%)		0/24 (0%)
Nervous system disorders
Dizziness	0/12 (0%)		1/24 (4.2%)
Headache	0/12 (0%)		2/24 (8.3%)
Renal and urinary disorders
Haematuria	0/12 (0%)		3/24 (12.5%)
Respiratory, thoracic and mediastinal disorders
Cough	0/12 (0%)		1/24 (4.2%)
Nasal congestion	1/12 (8.3%)		1/24 (4.2%)
Oropharyngeal pain	1/12 (8.3%)		5/24 (20.8%)
Rhinorrhoea	1/12 (8.3%)		1/24 (4.2%)
Skin and subcutaneous tissue disorders
Blister	0/12 (0%)		2/24 (8.3%)
Pruritus	0/12 (0%)		1/24 (4.2%)
Rash	0/12 (0%)		2/24 (8.3%)
Surgical and medical procedures
Abortion induced	1/12 (8.3%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.