ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH)
that is being developed for the treatment of growth hormone deficiency in adults and
children. ALTU-238 is designed to require fewer injections than the currently available
formulations of rhGH.
Inclusion Criteria:
- Growth hormone deficient men and women ages 18-60 years with a hypothalamic and/or
pituitary structural lesion or longstanding idiopathic GHD
- Growth hormone deficiency as determined by pituitary testing within the last five
years by either of the two following tests:
1. Insulin hypoglycemia (glucose < 50 mg/dL) with maximum GH < 5 ng/mL (5 µg/L) by
radioimmunoassay or < 2. 5 µg/L, if measured by immunoradiometric assay
2. Arginine-GHRH infusions with maximum GH < 5 ng/mL (5 µg/L) or < 2. 5 µg/L, if
measured by immunoradiometric assay
- Women must be of non-child bearing potential (hysterectomy, tubal ligation, or IUD are
acceptable) during the three months prior to entering the study, or post-menopausal
(no menses for one year or more), or six to twelve months without menses and
β-estradiol levels < 20 pg/mL
- Glucocorticoid use is allowed provided the subject has been on physiologic (<7. 5 mg
prednisone or equivalent/day) replacement doses for at least 3 months
- Free thyroxine (T4) within the normal range at Screening. If the subject is receiving
thyroid hormone replacement therapy, the dose must be stable for at least 6 weeks
prior to Screening
- Willing and able to provide written informed consent
- BMI 20 - 36 kg/m2
Exclusion Criteria:
- Any previous or ongoing clinically significant illness that, in the opinion of the
investigator, could prevent the subject from completing the study
- Any history of cancer within the past 5 years, except for dermal squamous and basal
cell carcinoma with documented 6-month remission. Subjects with a more recent history
of successfully treated cervical carcinoma in situ will not be excluded provided there
is documented 12-month remission
- BMI <20 or >36 kg/m2
- Any allergic or abnormal reaction to human growth hormone
- Inability of the subject to discontinue use of their regularly prescribed human growth
hormone treatment from six weeks prior to Day - 1 through the completion of the study
- Serum creatinine > 1. 4 mg/dL
- Hypocalcemia or hypercalcemia from any cause
- Hyperparathyroidism, osteomalacia or any other disorder which may affect bone and bone
markers including the use of bisphosphonates or other medications for osteoporosis
- Participation in another clinical trial 30 days prior to screening
- Demonstrated inability to comply with protocol requirements (e. g. uncooperative
attitude, inability to return for follow-up visits, history of medical non-compliance,
and/or poor likelihood of completing the study)
- Blood donation within 56 days of the screening visit
- Plasma donation within seven days of the screening visit
- Positive serum pregnancy test
- Women of child bearing potential
- Abuse of alcohol; to be determined by principal investigator
- Abuse of prescription or illicit drugs; to be determined by principal investigator
