Study of Belimumab Administered Subcutaneously to Healthy Subjects

Human Genome Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Multiple Dose Group: Belimumab SC 2 x 120 mg weekly; Biological: Single Dose Group: Belimumab IV 240 mg; Biological: Single Dose Group: Belimumab SC 1 x 240 mg; Biological: Multiple Dose Group: Belimumab SC 1 x 200 mg weekly; Biological: Single Dose Group: Belimumab SC 1 x 200 mg; Biological: Single Dose Group: Belimumab SC 2 x 120 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01583530

HGS1006-C1105

Details and patient eligibility

About

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.

Full description

This study is designed to evaluate the absolute bioavailability, pharmacokinetics, tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of belimumab administered subcutaneously (SC) to healthy subjects.

Enrollment: 118 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 6 patient groups

Belimumab IV 240 mg

Active Comparator group

Treatment:

Biological: Single Dose Group: Belimumab IV 240 mg

Belimumab SC 2 x 120 mg

Experimental group

Treatment:

Biological: Single Dose Group: Belimumab SC 2 x 120 mg

Belimumab SC 1 x 240 mg

Experimental group

Treatment:

Biological: Single Dose Group: Belimumab SC 1 x 240 mg

Belimumab SC 1 x 200 mg

Experimental group

Treatment:

Biological: Single Dose Group: Belimumab SC 1 x 200 mg

Belimumab SC 2 x 120 mg weekly

Experimental group

Treatment:

Biological: Multiple Dose Group: Belimumab SC 2 x 120 mg weekly

Belimumab SC 1 x 200 mg weekly

Experimental group

Treatment:

Biological: Multiple Dose Group: Belimumab SC 1 x 200 mg weekly