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Completed

NCT Number: NCT01583530

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.

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Key information

Conditions

Healthy Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach, Florida, United States

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About this study

This study is designed to evaluate the absolute bioavailability, pharmacokinetics, tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of belimumab administered subcutaneously (SC) to healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single Dose Group: Belimumab IV 240 mg

Biological

Belimumab IV 240 mg administered on Day 0

Other names: BENLYSTA™

Single Dose Group: Belimumab SC 2 x 120 mg

Biological

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

Other names: BENLYSTA™

Single Dose Group: Belimumab SC 1 x 240 mg

Biological

Belimumab SC 240 mg x 1 injection on Day 0

Other names: BENLYSTA™

Single Dose Group: Belimumab SC 1 x 200 mg

Biological

Belimumab SC 200 mg x 1 injection on Day 0

Other names: BENLYSTA™

Multiple Dose Group: Belimumab SC 2 x 120 mg weekly

Biological

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

Other names: BENLYSTA™

Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

Biological

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

Other names: BENLYSTA™

Primary outcomes

  1. Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

  2. Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

  3. 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

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

    AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.

  4. Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

    Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.

  5. Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70

    Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.

Secondary outcomes

  1. Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119

  2. Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119

  3. Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119

    AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.

  4. Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119

    Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.

  5. Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab

    Time frame: Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119

    Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.

  6. Number of Participants Who Experienced Adverse Events

    Time frame: Up to Day 119

    Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).

Sponsors and collaborators

Lead sponsor

Human Genome Sciences Inc.

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 24, 2012
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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