TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis

  • STATUS
    Recruiting
  • participants needed
    96
  • sponsor
    Theravance Biopharma
Updated on 29 January 2022
body mass index
carbon monoxide
spirometry
bronchoscopy
idiopathic pulmonary fibrosis
diffusion capacity of the lung for carbon monoxide

Summary

This is a Phase 1, 3-part, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1058 inhaled solution. Part A is a SAD study in healthy subjects, Part B is a MAD study in healthy subjects, and Part C is a multiple-dose study in subjects with IPF.

Description

A Phase 1, 3-part, randomized, double-blinded, placebo-controlled, first in human study.

Part A is a single ascending dose (SAD) study in up to 5 cohorts of 8 healthy subjects (6 active and 2 placebo).

Part B is a multiple ascending dose (MAD) study in up to 4 cohorts of 8 healthy subjects (6 active and 2 placebo).

Part C is a 28 day multiple-dose study in up to 2 cohorts of 12 IPF subjects (8 active and 4 placebo). The dose levels administered in Part C will not exceed those previously administered in Part B which were shown to be well tolerated.

Details
Condition Pulmonary Fibrosis, Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment Placebo, TD-1058
Clinical Study IdentifierNCT04589260
SponsorTheravance Biopharma
Last Modified on29 January 2022

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