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Study of Belimumab Administered Subcutaneously to Healthy Subjects

NCT01583530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2013-08-07

Study results available
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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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Human Genome Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583530 on ClinicalTrials.gov