Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males

Exclusion Criteria

• •Females.
• •Clinically significant active, acute, or chronic illness.
• •History of coagulation or bleeding disorders.
• •Clinically significant chronic or recent (within 21 days of dosing) acute gastrointestinal disorder with nausea, vomiting or diarrhea as a major symptom.
• •Received any vaccine within 3 weeks of study entry or plans to be vaccinated within 6 weeks after study injection.
• •History of significant cardiovascular or cerebrovascular disease.
• •History of evaluation for autoimmune disease including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), scleroderma or thyroiditis.
• •Significant psychiatric illness that could potentially interfere with the assessments during this study.
• •Subjects who have had prior surgery or a major infection within 6 months of dosing.
• •History of medications within 7 days of dosing, except vitamins and/or minerals.
• •History of Gilbert's disease.