HealthyPhase 1NCT00407472
ATS-1 Needle Free Injection Device Study-a Device for Administering r-hGH (Saizen) to Treat Growth Hormone Deficiency
A Phase 1 study testing ATS-1 needle free device in people with Healthy, run by EMD Serono.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ATS-1 needle free device
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Sep 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
About this study
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.
- Conditions
- Healthy
- Being tested
- ATS-1 needle free device
- Keywords
- Bio-equivalence study in healthy volunteers, indication, of product is growth hormone deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATS-1 needle free deviceDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anthony Priestley, MBChB MFPM, Principal investigator, Bourn Hall Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407472
- Sponsor's protocol ID
- 25821
- Status last verified
- Oct 2013
- First submitted
- 1 Dec 2006
- Last updated
- 22 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATS-1 Needle Free Injection Device Study-a Device for Administering r-hGH (Saizen) to Treat Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT00407472
- Acronym / sponsor ID
- 25821
- Conditions
- Healthy
- Keywords
- Bio-equivalence study in healthy volunteers, indication, of product is growth hormone deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATS-1 needle free device | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Priestley, MBChB MFPM principal investigator
Bourn Hall Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATS-1 needle free device in people with Healthy, run by EMD Serono.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.