Single and Multiple Ascending Dose Study of TD-8236 by Inhalation

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-8236 by Inhalation of Single Ascending Doses in Healthy Subjects (Part A) and Multiple Ascending Doses in Subjects With Stable, Mild Asthma (Part B), and Stable, Moderate-to-Severe Asthma (Part C)

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.

Inclusion Criteria:

• Male or female, 18 - 60 years old
• Willing and able to give informed consent and comply with the study
• 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
• Pre-bronchodilator FEV ≥ 70% predicted for MAD cohorts and >40% predicted for biomarker cohorts
• Treatment with inhaled corticosteroids with or without long acting beta agonists
• 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 measurements
• Any sign of respiratory tract infection within 6 weeks 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 exclusion criteria apply