A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 10/11/2018 |
| Start Date: | January 2011 |
| End Date: | July 2012 |
A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary Fibrosis
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.
the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease with a histological picture of
usual interstitial pneumonia and a deteriorating clinical course. The prognosis is poor.
Chronic alveolar inflammation with associated parenchymal remodeling is theorized to promote
an ongoing abnormal fibrogenic repair response. Corticosteroids and immunomodulatory agents
have not been shown to benefit IPF patients. Recently several published clinical studies have
indicated a strong correlation between IPF severity and/or disease progression and the levels
of specific plasma biomarker proteins related to epithelial cell health and extracellular
matrix turnover.
PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce
fibrosis.
This study is the first intravenous multiple-dose study in humans, and will be conducted in
patients with IPF. Patients will be randomized to receive either PRM-151 or placebo.
usual interstitial pneumonia and a deteriorating clinical course. The prognosis is poor.
Chronic alveolar inflammation with associated parenchymal remodeling is theorized to promote
an ongoing abnormal fibrogenic repair response. Corticosteroids and immunomodulatory agents
have not been shown to benefit IPF patients. Recently several published clinical studies have
indicated a strong correlation between IPF severity and/or disease progression and the levels
of specific plasma biomarker proteins related to epithelial cell health and extracellular
matrix turnover.
PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce
fibrosis.
This study is the first intravenous multiple-dose study in humans, and will be conducted in
patients with IPF. Patients will be randomized to receive either PRM-151 or placebo.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
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