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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00407472
• Date of registration: 01/12/2006
• Primary sponsor: EMD Serono
• Public title: ATS-1 Needle Free Injection Device Study-a Device for Administering r-hGH (Saizen)to Treat Growth Hormone Deficiency
• Date of first enrolment: September 2005
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00407472
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts

• Name: Anthony Priestley, MBChB MFPM
• Affiliation: Bourn Hall Clinic

Key inclusion & exclusion criteria

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



Age minimum: 21 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Device: ATS-1 needle free device

Secondary ID(s)

25821

Source(s) of Monetary Support

Please refer to primary and secondary sponsors