Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

Inclusion criteria

• Healthy male or female subjects, age 18-65 years, inclusive.
• BMI 18-33 kg/m2
• Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:

• LDL-C ≥3.24 mmol/L (≥125 mg/dL)
• Triglycerides (fasted) <2.7mmol/L (<239 mg/dL)
• ALT within normal limits

Exclusion criteria

• Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
• History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled
• Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
• Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study.
• Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies.
• Positive results on the following Screening laboratory tests: urine pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.