Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study

Exclusion Criteria

• •Subjects who are currently receiving or have previously received treatment for adult GHD or any other indication, including PGHD, with a commercial GH product other than Saizen® freeze-dried formulation
• •Subjects who had a chronic underlying disease within 6 months prior to screening or concomitant medication(s) that in the opinion of the investigator would exclude the subject from the trial
• •Subjects who have significant renal impairment
• •Subjects who have diabetes mellitus
• •Subjects who are immunosuppressed
• •Subjects who have a current malignancy or a history of any malignancy (excluding fully-treated basal cell carcinoma)
• •Subjects who have participated in another study and received an investigational drug within 30 days prior to screening visit
• •Subjects who have clinically significant abnormal laboratory value(s)
• •Subjects who have known hypersensitivity or allergy to exogenous human GH or any of the excipients or phenol, the bacteriostatic agent in the Saizen® solution for injection