NCT04589260

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

A Ph 1, Rndmzd, Dbl-Blinded, Pbo-Controlled, 4-Part Study to Eval the Safety, Tolerability, PK, and PD of TD-1058 Admin by Inhalation of Single (A) and Multiple (B) Ascending Doses in Healthy Subjs and Subjs With IPF (C) and Following Admin Microtracer Doses (D)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, 4-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, Part C is a multiple-dose study in subjects with IPF, and Part D studies lung bioavailability and renal elimination in Healthy Subjects.

Detailed 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. Part D studies lung bioavailability and renal elimination in Healthy Subjects.

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	TD-1058	Study drug to be administered by oral inhalation
DRUG	Placebo	Placebo to be administered by oral inhalation

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-05-06
• Completion: 2021-10-04
• First posted: 2020-10-19
• Last updated: 2022-02-23

Locations

1 site across 1 country: United Kingdom