ATS-1 Needle Free Injection Device Study-a Device for Administering r-hGH (Saizen) to Treat Growth Hormone Deficiency
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.
Inclusion Criteria:

 -  Male Subjects age 21 to 50

 -  Have given written informed consent

 -  Have a body weight greater than 60 kg and a body mass index (BMI) in the range of 22
 30 (BMI - weight (kg) / height (m) 2)

 -  Have vital signs in the following normal range:

 -  Oral body temperature: 35.0 - 37.5 0C

 -  Blood Pressure (BP): Supine BP after at least 3 minutes of supine rest Systolic BP: 90
 - 150 mm Hg, diastolic P: 50 - 95 mm Hg, Supine heart rate after at least 3 minutes of
 rest: 40 - 90 bpm

 -  Be non-smoker or smoke less than or equal to five cigarettes (or use an equivalent
 amount of tobacco per day and be willing not to smoke whilst resident in the clinical
 unit

 -  Be able to communicate well with the Principal Investigator and be willing to comply
 with the requirements of the entire study

 -  Agree to use barrier contraception (condom and spermicide) during the study and for
 three months following completion of the post study visit.

 Exclusion Criteria:

 -  Existence of any surgical or medical condition which in the opinion of the Principal
 Investigator might interfere with the absorption, distribution, metabolism or
 elimination of the investigational medicinal product or with the aims of the study

 -  Have any clinically significant abnormality in the results of the screening safety
 laboratory tests

 -  Have an clinically significant abnormality on the 12-lead resting ECG at screening

 -  Have positive results from virology examination for Hepatitis surface antigen (HBsAg)
 (not due to vaccination), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus
 (HIV 1 and 2) at screening

 -  History or presence of hypertension or other significant cardiovascular abnormalities

 -  History or presence of cholelithiasis

 -  Significant history or clinical evidence of auto-immune, gastrointestinal,
 hematological, haemaoppoietic, hepatic, neurological, pancreatic or renal disease

 -  History or presence of diabetes

 -  Definite or suspected personal history or family history of adverse drug reaction or
 hypersensitivity to drugs with similar chemical structure to somatotropin or
 somtostatin

 -  Use of any chronic medication

 -  Presence or history of any serious allergy (requiring hospitalization or prolonged
 systemic treatment)

 -  History or presence of drug or alcohol abuse. The limits of alcohol consumption for
 inclusion in the study are defined as an average daily intake of 3 units or a maximum
 weekly intake of grater than 21 units (1 unit equals 340 mL of beer, 115 mL of wine or
 43 mL or spirits)

 -  Loss or donation or more than 400 mL of blood in the 12 weeks before dosing

 -  Subjects who have used any prescription drugs within 2 weeks or over-the-counter
 medication (with the exception of paracetamol and multi-vitamins) within 1 week before
 dosing without prior approval from the investigator

 -  Administration of any investigational drug in the 12 weeks before dosing