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

• Status: Completed
• Trial end date: 2020-07-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Theravance Biopharma

Criteria

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