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

NCT01583530 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Human Genome Sciences Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	118
Start date	2011-02
Completion	2011-09

Conditions

• Healthy

Interventions

• Single Dose Group: Belimumab IV 240 mg
• Single Dose Group: Belimumab SC 2 x 120 mg
• Single Dose Group: Belimumab SC 1 x 240 mg
• Single Dose Group: Belimumab SC 1 x 200 mg
• Multiple Dose Group: Belimumab SC 2 x 120 mg weekly
• Multiple Dose Group: Belimumab SC 1 x 200 mg weekly

Primary outcomes

• Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) — Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
• Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC — Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70
• 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 — 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.
• Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC — 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.
• Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC — 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.

Countries

United States