CompletedPhase 1

Study of Belimumab Administered Subcutaneously to Healthy Subjects

United States118 participantsStarted 2011-02

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 day…

What they're measuring

Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)

Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC

Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC

Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC

Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC

Timeframe: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

Trial details

NCT IDNCT01583530

SponsorHuman Genome Sciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-09

Results submitted2012-05-22

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