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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04136145
• Date of registration: 21/10/2019
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: 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
• Scientific 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
• Date of first enrolment: October 28, 2019
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04136145
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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
- 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Belimumab for SC

Drug: Belimumab for IV

Primary Outcome(s)

Serum concentration of belimumab following intravenous administration [Time Frame: From the treatment dosing (Day 1) to the end of study (Day 71)]

Serum concentration of belimumab following subcutaneous administration [Time Frame: From the treatment dosing (Day 1) to the end of study (Day 71)]

Secondary Outcome(s)

Number of subjects with abnormal urine parameters [Time Frame: From Admission to unit (Day -1) to the end of study (Day 71)]

Number of subjects with abnormal clinical chemistry parameters [Time Frame: From Admission to unit (Day -1) to the end of study (Day 71)]

Number of subjects with serious adverse events (SAEs) [Time Frame: From the day of informed consent to the end of study (Day 71)]

Number of subjects with abnormal electrocardiogram (ECG) findings [Time Frame: From Screening Day to the end of study (Day 71)]

Number of subjects with abnormal vital signs [Time Frame: From the treatment dosing (Day 1) to the end of study (Day 71)]

Number of subjects with adverse events (AEs) [Time Frame: From the treatment dosing (Day 1) to the end of study (Day 71)]

Number of subjects with abnormal hematology parameters [Time Frame: From Admission to unit (Day -1) to the end of study (Day 71)]

Number of subjects with injection site reactions in SC group [Time Frame: From the treatment dosing (Day 1) to Day 5]

Secondary ID(s)

209629

Source(s) of Monetary Support

Please refer to primary and secondary sponsors