drugset / Trial / NCT03652038

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

NCT03652038 ↗

Phase 1 Completed 94 enrolled Theravance Biopharma
RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start
2018-11-07
Primary completion
2020-07-13
Completion
2020-07-13

Outcome

Met primary endpoint

release “We met our primary objectives with the Phase 1 Part C study in moderate-to-severe asthmatics dosing TD-8236 with an inhaled corticosteroid.” theravance.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject TD-8236 Unknown — Inhaled

Indications