Trial Outcomes & Findings for 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 (NCT NCT04136145)

Last Updated: 2020-12-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

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

Results posted on

2020-12-28

Participant Flow

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.

A total of 171 participants were screened and 36 participants were enrolled and randomized in the study.

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants 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 n=36 Participants Total of all reporting groups
Age, Continuous	27.9 Years STANDARD_DEVIATION 3.99 • n=5 Participants	29.1 Years STANDARD_DEVIATION 6.44 • n=7 Participants	28.7 Years STANDARD_DEVIATION 5.71 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	12 Participants n=5 Participants	24 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Serum Concentration of Belimumab Following Intravenous Administration 72 hours after end of infusion	32845.9 Nanograms per milliliter Standard Deviation 9835.93	—
Serum Concentration of Belimumab Following Intravenous Administration 96 hours after end of infusion	30995.0 Nanograms per milliliter Standard Deviation 6472.10	—
Serum Concentration of Belimumab Following Intravenous Administration 168 hours after end of infusion	23850.3 Nanograms per milliliter Standard Deviation 3898.42	—
Serum Concentration of Belimumab Following Intravenous Administration 336 hours after end of infusion	15930.7 Nanograms per milliliter Standard Deviation 3859.50	—
Serum Concentration of Belimumab Following Intravenous Administration 1008 hours after end of infusion	5838.3 Nanograms per milliliter Standard Deviation 1868.93	—
Serum Concentration of Belimumab Following Intravenous Administration 1344 hours after end of infusion	3146.7 Nanograms per milliliter Standard Deviation 1275.16	—
Serum Concentration of Belimumab Following Intravenous Administration 1680 hours after end of infusion	1916.6 Nanograms per milliliter Standard Deviation 936.49	—
Serum Concentration of Belimumab Following Intravenous Administration 6 hours after end of infusion	57450.1 Nanograms per milliliter Standard Deviation 7804.49	—
Serum Concentration of Belimumab Following Intravenous Administration 48 hours after end of infusion	40738.2 Nanograms per milliliter Standard Deviation 6858.36	—
Serum Concentration of Belimumab Following Intravenous Administration Pre-dose (prior to start of belimumab IV infusion)	0.0 Nanograms per milliliter Standard Deviation 0.00	—
Serum Concentration of Belimumab Following Intravenous Administration 30 minutes (after the start of infusion)	26567.4 Nanograms per milliliter Standard Deviation 3602.68	—
Serum Concentration of Belimumab Following Intravenous Administration 0 hour (end of infusion)	63403.2 Nanograms per milliliter Standard Deviation 6104.64	—
Serum Concentration of Belimumab Following Intravenous Administration 1hour after end of infusion	64474.6 Nanograms per milliliter Standard Deviation 9167.16	—
Serum Concentration of Belimumab Following Intravenous Administration 24 hours after end of infusion	50284.8 Nanograms per milliliter Standard Deviation 4898.92	—
Serum Concentration of Belimumab Following Intravenous Administration 504 hours after end of infusion	11291.5 Nanograms per milliliter Standard Deviation 3860.41	—
Serum Concentration of Belimumab Following Intravenous Administration 672 hours after end of infusion	10115.7 Nanograms per milliliter Standard Deviation 2289.97	—

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=24 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Serum Concentration of Belimumab Following Subcutaneous Administration Pre-dose	0.0 Nanograms per milliliter Standard Deviation 0.00	—
Serum Concentration of Belimumab Following Subcutaneous Administration 6 hours post-dose	963.8 Nanograms per milliliter Standard Deviation 875.47	—
Serum Concentration of Belimumab Following Subcutaneous Administration 24 hours post-dose	6255.4 Nanograms per milliliter Standard Deviation 4255.21	—
Serum Concentration of Belimumab Following Subcutaneous Administration 48 hours post-dose	11838.9 Nanograms per milliliter Standard Deviation 5838.53	—
Serum Concentration of Belimumab Following Subcutaneous Administration 72 hours post-dose	14501.9 Nanograms per milliliter Standard Deviation 6105.54	—
Serum Concentration of Belimumab Following Subcutaneous Administration 144 hours post-dose	16752.1 Nanograms per milliliter Standard Deviation 5184.15	—
Serum Concentration of Belimumab Following Subcutaneous Administration 168 hours post-dose	16825.5 Nanograms per milliliter Standard Deviation 5095.95	—
Serum Concentration of Belimumab Following Subcutaneous Administration 240 hours post-dose	17262.9 Nanograms per milliliter Standard Deviation 3702.00	—
Serum Concentration of Belimumab Following Subcutaneous Administration 336 hours post-dose	14724.2 Nanograms per milliliter Standard Deviation 3519.94	—
Serum Concentration of Belimumab Following Subcutaneous Administration 504 hours post-dose	11235.9 Nanograms per milliliter Standard Deviation 2928.08	—
Serum Concentration of Belimumab Following Subcutaneous Administration 672 hours post-dose	7551.1 Nanograms per milliliter Standard Deviation 2836.06	—
Serum Concentration of Belimumab Following Subcutaneous Administration 1008 hours post-dose	4720.3 Nanograms per milliliter Standard Deviation 1827.40	—
Serum Concentration of Belimumab Following Subcutaneous Administration 1344 hours post-dose	2651.6 Nanograms per milliliter Standard Deviation 1345.36	—
Serum Concentration of Belimumab Following Subcutaneous Administration 1680 hours post-dose	1365.7 Nanograms per milliliter Standard Deviation 931.47	—
Serum Concentration of Belimumab Following Subcutaneous Administration 96 hours post-dose	16682.3 Nanograms per milliliter Standard Deviation 6038.30	—
Serum Concentration of Belimumab Following Subcutaneous Administration 120 hours post-dose	16131.3 Nanograms per milliliter Standard Deviation 6055.17	—

SECONDARY outcome

Timeframe: Up to Day 71

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Number of Participants With Abnormal Vital Signs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 71

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Abnormal-Not Clinically significant	3 Participants	7 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Abnormal-Clinically significant	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Day 71

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Number of Participants With Abnormal Clinical Chemistry Parameters	12 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to Day 71

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Number of Participants With Abnormal Hematology Parameters	10 Participants	15 Participants

SECONDARY outcome

Timeframe: Up to Day 71

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Number of Participants With Abnormal Urinalysis Parameters	4 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to Day 71

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Number of Participants With Injection Site Reaction	0 Participants	19 Participants

SECONDARY outcome

Timeframe: Up to Day 71

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	Belimumab 200 mg IV n=12 Participants Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour.	Belimumab 200 mg SC n=24 Participants Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events Non-SAEs	11 Participants	24 Participants
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events SAEs	0 Participants	0 Participants

Adverse Events

Belimumab 200 mg IV

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Belimumab 200 mg SC

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER