A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed · Phase 1 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.

Key facts

Study ID

NCT01254409

Run by

Hoffmann-La Roche

People needed

21

Starts

2011-03-29

Expected to finish

2012-07-02

Last updated by the study team

2022-04-20

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women of non-childbearing potential aged 40 to 80 years at screening.
• Diagnosis of idiopathic pulmonary fibrosis (IPF) as determined by high resolution computerized tomography (HRCT) and pulmonary function tests.

You may not qualify if…

• History or presence of connective tissue disorder, tuberculosis (TB), cystic fibrosis, sarcoidosis, amyloidosis or other pulmonary disease except idiopathic pulmonary fibrosis (IPF).
• History or presence of chronic pulmonary obstructive disease, severe pulmonary hypertension, drug-induced pulmonary toxicity, other forms of idiopathic pneumonia, or interstitial lung diseases associated with environmental exposure medication or systemic disease.
• High resolution computerized tomography (HRCT) findings inconsistent with idiopathic pulmonary fibrosis(IPF).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Duke Clinical Research Unit — Durham, North Carolina, United States
• Center for Human Drug Research — Leiden, Netherlands

Full record on ClinicalTrials.gov

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