Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response

• Status: Completed
• Trial end date: 2020-08-28
• Target enrollment: 0
• Participant gender: All

Summary

This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theravance Biopharma

Criteria

Inclusion Criteria:

• Male or female, 18 to 65 years of age

• Willing and able to give informed consent and comply with study requirements

• Documented physician-diagnosed asthma for ≥ 4 months prior to Screening

• Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Screening.

• Women of child bearing potential must have a negative pregnancy test

• Males and females must use a highly efficient birth control method

• Pre-bronchodilator FEV1 ≥ 70% predicted

• Documented allergy to at least one common allergen

• Dual responder to inhaled bronchial challenges

• 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

• History of life-threatening asthma

• Uses or have used tobacco or nicotine-containing products within 6 months prior to screening

• Additional exclusion criteria apply