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NCT01583530 · ClinicalTrials.gov registry record · Phase 1

Study of Belimumab Administered Subcutaneously to Healthy Subjects

A Phase 1 study, sponsored by Human Genome Sciences.

Completed
Registry status
Phase 1
Development phase
118
Enrollment target

NCT01583530 is a Phase 1 study that has completed, run by Human Genome Sciences. The registered enrollment target is 118 participants.

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The verdict

NCT01583530, a Phase 1 study, has completed, sponsored by Human Genome Sciences.

COMPLETED
Registry status
Phase 1
Development phase
118 participants
Enrollment target

Study 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.

Interventions

  • BIOLOGICAL 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

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2011-02
Est. Completion 2011-09
Phase Phase 1

Sponsor

Human Genome Sciences

17 total trials

What the Registry Record Tells You About NCT01583530

The ClinicalTrials.gov registry entry for NCT01583530 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Single Dose Group: Belimumab IV 240 mg is the first listed.

NCT01583530 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01583530 about?

NCT01583530 is a clinical study titled "Study of Belimumab Administered Subcutaneously to Healthy Subjects". 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.

What is the current status of trial NCT01583530?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2011-02. Estimated completion is 2011-09.

What interventions are being tested in trial NCT01583530?

The interventions under investigation include: 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).

Who is sponsoring clinical trial NCT01583530?

This trial is sponsored by Human Genome Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.