Study of Belimumab Administered Subcutaneously to Healthy Subjects
Public ClinicalTrials.gov record NCT01583530. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01583530
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 118 participants
Conditions and interventions
Conditions
Interventions
- Single Dose Group: Belimumab IV 240 mg Biological
- Single Dose Group: Belimumab SC 2 x 120 mg Biological
- Single Dose Group: Belimumab SC 1 x 240 mg Biological
- Single Dose Group: Belimumab SC 1 x 200 mg Biological
- Multiple Dose Group: Belimumab SC 2 x 120 mg weekly Biological
- Multiple Dose Group: Belimumab SC 1 x 200 mg weekly Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2011
- Primary completion
- Aug 31, 2011
- Completion
- Aug 31, 2011
- Last update posted
- Aug 6, 2013
2011
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Daytona Beach | Florida | — | — |
| Not listed | Evansville | Indiana | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Madison | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01583530, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2013 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01583530 live on ClinicalTrials.gov.