CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 118 enrolled
Drug / intervention
Single Dose Group: Belimumab IV 240 mg +5 morebiological
Likely dose
Single Dose Group: Belimumab IV 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01583530
NCT01583530Phase 1Completed
CompareCT.gov

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

Human Genome Sciences Inc.·interventional·Posted Apr 24, 2012·Updated Aug 7, 2013

In Brief

A Phase 1 clinical trial evaluating Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, and 4 other interventions for Healthy. Completed, enrolled 118 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2012
Enrollment StartFeb 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.2 years ago

Interventions

Single Dose Group: Belimumab IV 240 mgbiological

Belimumab IV 240 mg administered on Day 0

Single Dose Group: Belimumab SC 2 x 120 mgbiological

Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0

Single Dose Group: Belimumab SC 1 x 240 mgbiological

Belimumab SC 240 mg x 1 injection on Day 0

Single Dose Group: Belimumab SC 1 x 200 mgbiological

Belimumab SC 200 mg x 1 injection on Day 0

Multiple Dose Group: Belimumab SC 2 x 120 mg weeklybiological

Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21

Multiple Dose Group: Belimumab SC 1 x 200 mg weeklybiological

Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21