Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.

Inclusion Criteria:

• Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory.
• Body mass index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion Criteria:

• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.