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A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects

NCT01894360 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2017-05-15

No results posted yet for this study

Summary

This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects using a prefilled syringe or autoinjector. This study will also assess the usability and reliability of the injection devices. A total of approximately 80 subjects (40 per group) will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0 milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned injection device. Subjects will continue to be followed for 70 days after the administration of belimumab.

Conditions

Interventions

DRUG

Belimumab 200 mg/mL

Clear to opalescent, colorless to pale yellow sterile solution sterile solution for SC injection in a single-use liquid formulation of Belimumab 200 mg/mL will be supplied in 1mL long glass prefilled syringe or autoinjector device.

Sponsors & Collaborators

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
2013-10-14
Primary Completion
2014-05-13
Completion
2014-05-13

Countries

  • United States

Study Locations

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Diseases
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 NCT01894360 on ClinicalTrials.gov