A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PRM151F-12GL)
Idiopathic Pulmonary Fibrosis
|Study Design:||Allocation: Randomized
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|
- Safety and Tolerability [ Time Frame: From first dose on Day 1 through Day 57 ]Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events
- Cmax [ Time Frame: Day 15 ]Maximum concentration
- Tmax [ Time Frame: Day 15 ]Time of Maximum observed concentration
- AUC48 [ Time Frame: Day 15 ]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 ]
- Total Body Clearance [ Time Frame: Day 15 ]
- Vss [ Time Frame: Day 15 ]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 ]
- 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 ]
- FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline [ Time Frame: Day 1 (Baseline) and Day 57 ]
- 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline [ Time Frame: Screening (between Day -35 and Day 1) and Day 57 ]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 ]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.
|Study Start Date:||January 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
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.
Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254409
|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|
|Center for Human Drug Research|
|Study Director:||John Getsy, DMD, DO||Promedior, Inc.|