NCT01254409

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 29, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 3, 2014

Completed
Last Updated

April 20, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

December 3, 2010

Results QC Date

April 11, 2014

Last Update Submit

March 31, 2022

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

pulmonary, fibrosis

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

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

    From first dose on Day 1 through Day 57

Secondary Outcomes (12)

  • Cmax

    Day 15

  • Tmax

    Day 15

  • AUC48

    Day 15

  • Terminal Elimination Half Life

    Day 15

  • Total Body Clearance

    Day 15

  • +7 more secondary outcomes

Study Arms (2)

PRM-151

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

0.9% saline administered by 30 minute IV infusion Days 1, 3, 5, 8, and 15.

Other: Placebo

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.

PRM-151
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Location

Center for Human Drug Research

Leiden, Netherlands

Location

Related Publications (1)

  • van den Blink B, Dillingh MR, Ginns LC, Morrison LD, Moerland M, Wijsenbeek M, Trehu EG, Bartholmai BJ, Burggraaf J. Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Eur Respir J. 2016 Mar;47(3):889-97. doi: 10.1183/13993003.00850-2015. Epub 2016 Feb 11.

    PMID: 26869678DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisPulmonary Fibrosis

Interventions

PRM-151

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Bernt van den Blink
Organization
Promedior, Inc.
bvandenblink@promedior.com
781-538-4203

Study Officials

  • John Getsy, DMD, DO

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

March 29, 2011

Primary Completion

July 2, 2012

Study Completion

July 2, 2012

Last Updated

April 20, 2022

Results First Posted

November 3, 2014

Record last verified: 2022-03

Locations

US(2)NL(1)