Phase 1
Completed N=118
Study of Belimumab Administered Subcutaneously to Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01583530 ↗
Enrolled (actual)
118
Serious AEs
1.7%
Results posted
Aug 2012
Primary outcomePrimary: Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) — 0.09; 3.9; 4.9; 5.9 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) |
0.09; 3.9; 4.9; 5.9 | — |
| PRIMARY Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC |
86.2; 32.7; 31.6; 24.3 | — |
| PRIMARY Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC |
1030; 788; 812; 612 | — |
| PRIMARY Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC |
18.2; 15.9; 18.2; 16.0 | — |
| PRIMARY Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC |
NA; 76.1; 81.8; 73.5 | — |
| SECONDARY Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab |
5.8; 5.5 | — |
| SECONDARY Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab |
21.6; 19.5 | — |
| SECONDARY Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab |
763; 661 | — |
| SECONDARY Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab |
20.3; 19.8 | — |
| SECONDARY Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab |
74.7; 77.9 | — |
| SECONDARY Number of Participants Who Experienced Adverse Events |
14; 11; 16; 14; 18; 19 | — |
Eligibility Criteria
Key Inclusion Criteria
- Healthy subjects defined as no clinically relevant abnormalities identified by a detailed medical history, full physical exam, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Body weight between 45 to 120 kg (99 to 264 lbs).
- Must agree to use effective contraception throughout the study and for 14 weeks after administration of belimumab.
- Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.
Key Exclusion Criteria
- Pregnant or nursing.
- Test positive for drugs or alcohol or have had a drug or alcohol dependence within the past year.
- Have used any prescription medicines within the past 30 days or herbal/botanical supplements within the past 7 days or anticipate use during the study. May use prescription contraceptives, hormone replacement therapy, and over-the-counter medicines such as antihistamines or nutritional support such as vitamins, minerals, or amino acids.
- Have received a live vaccine within the past 30 days or anticipate receipt of a live vaccine during the study and within 4 months after last injection of belimumab.
- Have a history of an allergic or anaphylactic reaction to drugs, food, or insect bite or sting requiring medical intervention.
- Have a history of allergic reaction to contrast agents or biological medicines.
- Have participated in a clinical trial and received an experimental medicine within the past 60 days.
- Have received treatment with a B cell targeted therapy at any time.
- Have required management of an infection within the past 14 days.
Data sourced from ClinicalTrials.gov (NCT01583530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.