Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects

A Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-5202 in Healthy Subjects

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.

Inclusion Criteria:

• Male or female, 19 - 55 years old
• Willing and able to give informed consent and comply with the study
• Medically healthy with no clinically significant medical history
• Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
• Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
• Males must use acceptable contraception
• Additional inclusion criteria apply

Exclusion Criteria:

• Positive for hepatitis A, B or C, HIV or tuberculosis
• Clinically significant abnormalities of laboratory evaluations
• Have abnormal ECG or vital sign measurements
• Any acute illness at time of screening
• Have a current bacterial, parasitic, fungal or viral infection
• Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
• Additional inclusion criteria apply