ATS-1 Needle Free Injection Device Study-a Device for Administering r-hGH (Saizen)to Treat Growth Hormone Deficiency
This study was a Phase I, open label, randomized, 2-period, 2-sequence, crossover study designed to assess the relative bioavailability of Saizen administered by the ATS-1 needle-free injection device and a standard needle and syringe. Informed consent was obtained prior to screening. All screening assessments establishing subject eligibility were performed in the 21 days before dosing. Randomization Pre-dose on Day 1, subjects were randomized to one of the two treatment sequences: Sequence 1: SC Saizen administered by the Standard needle and syringe (Period 1) followed by the administration using the ATS-1 device (Period 2). Sequence 2: SC Saizen administered by the ATS-1 device (Period 1) followed by administration using the standard needle and syringe (Period 2).
Subjects were resident at the Unit from approximately 19:00 on Day -1 until Day 2 (approximately 30 hours (h) post dose) of each treatment period. An IV Stilamin infusion was commenced 1 h before. Saizen administration and stopped immediately after the last pharmacokinetic (PK) blood sample has been taken, i.e. a 25 h infusion. Stilamin was administered as a constant IV infusion at a rate of approximately 118 mg/h (40 mL/h), which corresponds to 1.65 mg/kg body weight/h for a person weighing 70kg. Dosing with Saizen occurred between approximately 0800 and 0900 h on Day 1 of each treatment period after an overnight fast of at least 10h. Subjects were dosed with Saizen at the same time on Day 1 in Periods 1 and 2. There was a minimum of 7-day washout between treatment periods 1 and 2.
Laboratory safety tests, ECGs were taken at protocol specified time points and blood samples for the assessment of glucose and growth hormone were taken immediately predose and 1, 2, 3, 4 4.5, 5, 5.5, 6, 7, 8, 12, 18 and 24 h post dose. A post-study visit took place 33+/- 3 days after dosing a treatment period 2.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment