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A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PRM151F-12GL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Promedior, Inc.
ClinicalTrials.gov Identifier:
NCT01254409
First received: December 3, 2010
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Biological: PRM-151
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Promedior, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: From first dose on Day through Day 57 ] [ Designated as safety issue: Yes ]
    Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events


Secondary Outcome Measures:
  • Cmax [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Maximum concentration

  • Tmax [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Time of Maximum observed concentration

  • AUC48 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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.

  • Terminal Elimination Half Life [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Total Body Clearance [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Vss [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Volume of Distribution at Steady State

  • FVC (Forced Vital Capacity) Change From Baseline to Day 57 [ Time Frame: Change from Day 1 (Baseline) to Day 57 ] [ Designated as safety issue: No ]
  • FVC (Forced Vital Capacity) % Predicted Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ] [ Designated as safety issue: No ]
  • DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ] [ Designated as safety issue: No ]
  • FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ] [ Designated as safety issue: No ]
  • 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline [ Time Frame: Screening (between Day -35 and Day 1) and Day 57 ] [ Designated as safety issue: No ]
    Change from baseline (measured during screening period) in distance walked during a 6 minute walk test

  • SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ] [ Designated as safety issue: No ]
    St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.


Enrollment: 21
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRM-151
PRM-151 administered at escalating doses of 1, 5, and 10 mg/kg by 30 minute intravenous (IV) infusion days 1, 3, 5, 8 and 15.
Biological: PRM-151
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.
Placebo Comparator: Placebo
0.9% saline administered by 30 minute IV infusion Days 1, 3, 5, 8, and 15.
Other: Placebo
Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254409

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
Netherlands
Center for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Promedior, Inc.
Investigators
Study Director: John Getsy, DMD, DO Promedior, Inc.
  More Information

No publications provided

Responsible Party: Promedior, Inc.
ClinicalTrials.gov Identifier: NCT01254409     History of Changes
Other Study ID Numbers: PRM151F-12GL
Study First Received: December 3, 2010
Results First Received: April 11, 2014
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Promedior, Inc.:
pulmonary, fibrosis

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014