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

Hoffmann-La Roche21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

PRM-151BIOLOGICAL

Intravenous PRM-151 administered over 30 minutes on study days 1, 3, 5, 8, and 15 at doses of 1.0, 5.0, or 10.0 mg/kg.

PlaceboOTHER

Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke Clinical Research Unit

Durham, North Carolina, United States

Center for Human Drug Research

Leiden, Netherlands

Outcomes

Primary Outcomes

Safety and Tolerability

Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events

Time frame: From first dose on Day 1 through Day 57

Secondary Outcomes

Cmax

Maximum concentration

Time frame: Day 15

Tmax

Time of Maximum observed concentration

Time frame: Day 15

AUC48

Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.

Time frame: Day 15

Terminal Elimination Half Life

Time frame: Day 15

Total Body Clearance

Time frame: Day 15

Vss

Volume of Distribution at Steady State

Time frame: Day 15

FVC (Forced Vital Capacity) Change From Baseline to Day 57

Time frame: Change from Day 1 (Baseline) to Day 57

FVC (Forced Vital Capacity) % Predicted Change From Baseline

Time frame: Day 1 (Baseline) and Day 57

DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline

Time frame: Day 1 (Baseline) and Day 57

Data from ClinicalTrials.gov

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