Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10

A Phase 1 Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of AG10 in Healthy Subjects

This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects

Up to 48 healthy volunteers will be given a single dose of AG10 or placebo and be monitored for safety and tolerability over a 5-day period. Up to 48 healthy volunteers will be given multiple doses of AG10 or placebo and be monitored for safety and tolerability over a 15-day period.

Inclusion Criteria:

• Weight between >50 kg and ≤110 kg;
• BMI of 18 to 32 kg/m2;
• Subjects who are healthy as determined by medical history, physical examination, 12 lead ECG and standard laboratory tests;
• Subjects who are negative for drugs of abuse and alcohol tests;
• Subjects who are non-smokers;

Exclusion Criteria:

• Subjects who have used prescription drugs within 4 weeks of first dosing;
• Subjects who have a prior cholecystectomy;
• Subjects who have used any over-the-counter medications within 7 days prior to Day -1;
• Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders;
• Subjects who have an abnormal screening ECG;