A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults

Exclusion Criteria

• •1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
• •2. History of hypersensitivity to antibodies.
• •3. A history of clinically significant ECG abnormalities, which, in the opinion of the investigator, may indicate active cardiac disease.
• •4. History of malignancy of any organ system (other than localized nonmelanomatous cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• •5. Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, COPD, chronic kidney disease (estimated GFR \< 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus.
• •6. Diseases known to cause malabsorption of protein or energy, including inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency, etc.
• •7. Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), γ-GT, alkaline phosphatase, or serum bilirubin (except Gilbert's
• •Disease). The Investigator should be guided by the following criteria:
• •Any single transaminase listed above may not exceed 3x upper limit of normal (ULN).
• •If the total bilirubin concentration is increased above 1.5 x ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1.6 mg/dL (27 μmol/L). 8. Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, etc. 9. Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation. 10. Plasma donation (\> 250 mL) within 14 days prior to first dosing. 11. Hemoglobin concentration below 11.0 g/dL at screening. 12. Significant illness within two (2) weeks prior to initial dosing. 13. Patients with known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit administration of MRI assessments. 14. Patient smokes more than one cigarette, pipe or cigar a month