Study of Belimumab Administered Subcutaneously to Healthy Subjects
Condition: Healthy
Intervention: Single Dose Group: Belimumab IV 240 mg; Single Dose Group: Belimumab SC 2 x 120 mg; Single Dose Group: Belimumab SC 1 x 240 mg; Single Dose Group: Belimumab SC 1 x 200 mg; Multiple Dose Group: Belimumab SC 2 x 120 mg weekly; Multiple Dose Group: Belimumab SC 1 x 200 mg weekly
Intervention description: Belimumab IV 240 mg administered on Day 0; Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0; Belimumab SC 240 mg x 1 injection on Day 0; Belimumab SC 200 mg x 1 injection on Day 0; Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21; Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
Intervention MeSH terms: Belimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Belimumab; Injections, Subcutaneous; Drug Administration Routes; Injections; Lupus Erythematosus, Systemic; Lupus; SLE; Systemic Lupus Erythematosus; Antibodies; Autoimmune Disease; Biological Therapy; Immune System Diseases; Pharmacokinetics; Biological Availability

Summary:

      The purpose of this study is to measure the amount of belimumab in the blood when given as an
      injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of
      multiple injections under the skin in healthy subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy subjects defined as no clinically relevant abnormalities identified by a
             detailed medical history, full physical exam, 12-lead electrocardiogram (ECG), and
             clinical laboratory tests.

          -  Body weight between 45 to 120 kg (99 to 264 lbs).

          -  Must agree to use effective contraception throughout the study and for 14 weeks after
             administration of belimumab.

          -  Have the ability to understand the requirements of the study, provide written informed
             consent, and comply with the study protocol procedures.

        Key Exclusion Criteria:

          -  Pregnant or nursing.

          -  Test positive for drugs or alcohol or have had a drug or alcohol dependence within the
             past year.

          -  Have used any prescription medicines within the past 30 days or herbal/botanical
             supplements within the past 7 days or anticipate use during the study. May use
             prescription contraceptives, hormone replacement therapy, and over-the-counter
             medicines such as antihistamines or nutritional support such as vitamins, minerals, or
             amino acids.

          -  Have received a live vaccine within the past 30 days or anticipate receipt of a live
             vaccine during the study and within 4 months after last injection of belimumab.

          -  Have a history of an allergic or anaphylactic reaction to drugs, food, or insect bite
             or sting requiring medical intervention.

          -  Have a history of allergic reaction to contrast agents or biological medicines.

          -  Have participated in a clinical trial and received an experimental medicine within the
             past 60 days.

          -  Have received treatment with a B cell targeted therapy at any time.

          -  Have required management of an infection within the past 14 days.