NCT01583530

Study of Belimumab Administered Subcutaneously to Healthy Subjects

A Randomized, Parallel-Group, Open-Label Study to Evaluate the Absolute Bioavailability, Pharmacokinetics, Tolerability and Safety of a High Concentration Formulation of Belimumab (HGS1006), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Human Genome Sciences Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Single Dose Group: Belimumab IV 240 mg	Belimumab IV 240 mg administered on Day 0
BIOLOGICAL	Single Dose Group: Belimumab SC 2 x 120 mg	Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
BIOLOGICAL	Single Dose Group: Belimumab SC 1 x 240 mg	Belimumab SC 240 mg x 1 injection on Day 0
BIOLOGICAL	Single Dose Group: Belimumab SC 1 x 200 mg	Belimumab SC 200 mg x 1 injection on Day 0
BIOLOGICAL	Multiple Dose Group: Belimumab SC 2 x 120 mg weekly	Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
BIOLOGICAL	Multiple Dose Group: Belimumab SC 1 x 200 mg weekly	Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2012-04-24
• Last updated: 2013-08-07
• Results posted: 2012-08-28

Locations

4 sites across 1 country: United States