ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability

Inclusion Criteria: * Male or female healthy volunteers, age 18 to 60 years, inclusive * Overweight to obese (BMI 25.0 - 40.0 kg/m2) * MRI-PDFF≥ 10% (Part 2 only) * Non-smokers or ex-smokers (must have ceased smoking \> 1 months prior to screening visit) * Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication * Ability and willingness to attend the necessary visits to the study center * Written informed consent signed prior to entry into the study Exclusion Criteria: * Women who are pregnant or breastfeeding * History of pancreatitis * History of or acute significant GI disorder * History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5% * History of clinically significant endocrine (eg, hypothyroidism), neurological, GI, cardiovascular (except controlled hypertension and hypercholesterolemia), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * History of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions: 1. Adequately treated non-melanomatous skin carcinoma 2. Female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician * Blood pressure \> 150/90 mmHg or heart rate \> 100 beats per minute at screening and at Day -1 * Clinically significant laboratory abnormalities including: Impaired renal function (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73m2) as estimated using the MDRD equation at screening: 1. GFR (mL/min/1.73 m²) = 175 × (SCr/88.4)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) (SI units), where SCr is standardized serum creatinine in SI units (µmol/L) and age is in years 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values \> 2 × upper normal limits 3. Calcitonin \> 50 ng/L - Excessive alcohol consumption defined as \>21 alcohol units per week for males and as \>14 alcohol units per week for females (where 1 unit = half pint of beer, 25 mL of 40% spirit, or 125 mL of wine)