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Safety and Pharmacokinetics Study With AB0024 in Patients With Idiopathic Pulmonary Fibrosis.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Arresto Biosciences, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Arresto Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01242189
First received: November 12, 2010
Last updated: November 15, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this phase I, dose escalation study is to evaluate AB0024 in patients with Idiopathic Pulmonary Fibrosis.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
 Drug: AB0024
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 Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Idiopathic Pulmonary Fibrosis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arresto Biosciences, Inc.:

Primary Outcome Measures:
  • To characterize the safety of AB0024 after multiple administrations in patients with Idiopathic Pulmonary Fibrosis. [ Time Frame: 85 days ] [ Designated as safety issue: Yes ]
    To characterize the safety of AB0024 after 3 administrations in patients with Idiopathic Pulmonary Fibrosis by weekly clinical assessments out to day 85.

  • To characterize the pharmacokinetics of AB0024 after administration in patients with Idiopathic Pulmonary Fibrosis. [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of AB0024 after 3 administrations in patients with Idiopathic Pulmonary Fibrosis with weekly assessments out to day 85.


Estimated Enrollment: 18
Study Start Date: December 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: AB0024
AB0024 administered at 3mg, 10mg or 20mg.
Placebo Comparator: Placebo Other: Placebo
Normal Saline

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acceptable results on pulmonary function tests
  • At rest oxygen saturation ≥90% on room air
  • Adequate organ function

Exclusion Criteria:

  • High resolution computer tomography pattern showing emphysema that is greater than fibrosis
  • Acceptable results on whole body plethysmography
  • History of clinically significant hepatic or renal disease
  • Poorly controlled or severe diabetes mellitus
  • Use of systemic immunosuppressants within 28 days of AB0024 infusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242189

Locations
United States, California
David Geffen School of Medicine at UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Eileen Callahan     310-794-2466     ecallahan@mednet.ucla.edu    
Principal Investigator: Samuel Weigt, MD            
Stanford University Medical Center Not yet recruiting
Palo Alto, California, United States, 94305
Contact: Susan Jacobs     650-725-8082     ssjpulm@stanford.edu    
Principal Investigator: Glen Rosen, MD            
United States, Pennsylvania
UPMC Translational Research Center Not yet recruiting
Pittsburg, Pennsylvania, United States, 15213
Contact: Michelle Meyers     412-692-2149     meyersma@upmc.edu    
Principal Investigator: Kevin Gibson, MD            
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Ashley Knight     843-792-0373     knightae@musc.edu    
Principal Investigator: Steven Sahn, MD            
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Rhonda Greer     615-343-7068     rhonda.greer@vanderbilt.edu    
Principal Investigator: Lisa Lancaster, MD            
Sponsors and Collaborators
Arresto Biosciences, Inc.
Investigators
Study Director: Dung Thai, MD, PhD Arresto Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Dung Thai, MD, PhD, Arresto Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01242189     History of Changes
Other Study ID Numbers: AB0024-201
Study First Received: November 12, 2010
Last Updated: November 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Arresto Biosciences, Inc.:
Idiopathic Pulmonary Fibrosis

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

ClinicalTrials.gov processed this record on June 18, 2013