Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KER-047 Administered to Healthy Male Volunteers and Postmenopausal Female Volunteers

Exclusion Criteria14

• History of or current malignancy (excluding non-melanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years);
• Use of any prescription or over-the-counter medications taken within 7 days prior to dosing should be discussed with Investigator and Sponsor Medical Monitor (if deemed necessary). Use of medication should be ceased prior to dosing. Subject may be enrolled if the medication taken is not expected to interfere either with safety or study results;
• Clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease;
• Chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety ;
• History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia);
• Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening;
• History of severe allergic or anaphylactic reactions;
• Surgery within the previous 3 months to screening (other than minor cosmetic surgery or minor dental procedures);
• Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening that has not resolved prior to dosing;
• Clinically relevant/significant laboratory findings (up to 2 repeats permitted) at screening including, but not limited to:
• Alanine transaminase and Aspartate transaminase > 1.0 x upper limit of normal (ULN), isolated and mainly unconjugated hyperbilirubinemia consistent with Gilbert's should not be excluded;
• Creatinine outside normal laboratory range;
• Serum creatine kinase > 1.5 x ULN;
• Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month or 7 half-lives prior to dosing.