The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three
dose levels study in healthy Caucasian and Japanese male volunteers.
Following a 4-week screening period, eligible male subjects will be stratified by ethnic
group and will be randomized to one of six groups. On dosing day, designated as Day 1, each
subject will receive single SC injection of study medication according to group allocation
and will be followed up for a month for safety monitoring.
1. Healthy male volunteers, 18 to 45 years of age (inclusive).
2. Body Mass Index (BMI) 18 to 30 kg/m2 (inclusive) and weighing at least 55 kg.
3. Subjects in generally good health in the opinion of the investigator as determined by
medical history, vital signs and a physical examination.
4. Blood pressure and heart rate within normal limits.
5. Electrocardiogram (ECG) with no clinically significant abnormalities recorded at
screening visit (up to 28 days before dosing) and on dosing day (before drug
6. Negative HIV, hepatitis B and hepatitis C serology tests at screening
7. No clinically significant abnormalities in complete blood count (CBC), international
normalized ratio (INR), chemistry lab tests (liver and renal function) and urinalysis
8. No history of alcohol or drug abuse within 1 year of screening. Negative urine
drugs-of-abuse (DOA) in screening and on admission. Negative breath alcohol on
9. Subjects must agree to use medically accepted form of contraception from dosing day
to 12 weeks after drug administration.
10. Subjects must be able to understand the requirements of the study and must be willing
to comply with the requirements of the study and to provide their written informed
consent to participate in the study.
1. History of significant neurological (including history of seizures or EEG
abnormalities), renal, cardiovascular (including known structural cardiac
abnormalities or hypertension), respiratory (asthma), endocrinological,
gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety,
tension or agitation) or any other clinically significant medical disorder, which in
the investigator's judgment contraindicate administration of the study medication.
2. Known allergy to growth hormone or any constituents or ingredients or components in
3. Adherence (for whatever reason) to an abnormal diet (including any dietary
restrictions, e.g. low fat, lactose-free, low sodium, high protein, gluten-free,
organic, etc.) during the 4 weeks prior to the study, or subjects with recent
significant change in body weight.
4. Use of any prescription or over-the-counter (OTC) medications, including vitamins and
herbal or dietary supplements within 14 days prior to dosing. Brief use of OTC
medications for symptomatic relief of pain until 24 hours prior to and 48 hours after
the study drug administration may be allowed per the discretion of the medical
5. Subjects who have received any vaccines within 4 weeks prior to study drug
6. Subjects who donated blood or received blood or plasma derivatives in the one month
preceding signing of consent form.
7. Systemic corticosteroids other than in replacement doses within the 3 months before
study entry (temporary adjustment of glucocorticoids, as appropriate, is acceptable)
8. Anabolic steroids other than gonadal steroid replacement therapy within 2 months
before study entry
9. Participation in another clinical trial with drugs within one month of signing of
consent form (calculated from the previous study's last dosing date).
10. Subjects with an inability to communicate well with the investigators and clinic
staff [i.e., language problem (except Japanese speakers), poor mental development or
impaired cerebral function].
11. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of
study start, which is considered of significance by the Principal Investigator. Use
of investigational products (within 30 days of screening visit).