NCT03652038

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	TD-8236	Study drug to be administered via inhaler device
DRUG	Placebo	Placebo to be administered via inhaler device

Timeline

• Start date: 2018-11-07
• Primary completion: 2020-07-13
• Completion: 2020-07-13
• First posted: 2018-08-29
• Last updated: 2021-09-30

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study