Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency

Inclusion Criteria: * Male and female subjects between the ages of 18 and 45 years (inclusive). * Written informed consent to participate in the study. * Body mass index between 19 and 31 kg/m². * Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from 3 months prior through 7 days following the last dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum). Subjects must have used the same method for at least 3 months prior to starting the study. * No clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results during screening. * Screening growth hormone and insulin-like growth factor I (IGF-I) within normal limits. Exclusion Criteria * A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principle Investigator, would jeopardize the safety of the subject or impact the validity of the study results. * A history of allergic or adverse responses to growth hormone, glycerin, or metacresol, or any comparable or similar product. * Subjects who (for whatever reason) have been on an abnormal diet duri…