Single Ascending Dose Study of TD-1439 in Healthy Subjects

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-1439 in Healthy Subjects

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects

Inclusion Criteria:

• Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
• Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
• Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
• Males must abstain from sex or use highly effective methods of birth control
• Negative for HIV, and Hepatitis A, B, and C

Exclusion Criteria:

• Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
• Subjects with a history of angioedema.
• Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
• Subject has acute illness (gastrointestinal, infection [e.g., influenza] or known inflammatory process)
• Subject bradycardia
• Subject has hypertension
• Subjects has orthostatic hypotension
• Subjects has orthostatic tachycardia
• Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
• Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
• Additional exclusion criteria apply