Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis

July 11, 2023 updated by: FibroGen

A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring and thickening of the lungs. Participants will be assigned sequentially to one of the 3 dose group: Low, medium, and high FG-3019.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Sciences
    • Texas
      • Dallas, Texas, United States, 75390
        • Southwestern Medical School
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and surgical lung biopsy or according to the American Thoracic Society criteria

Key Exclusion Criteria:

  • have a history of significant exposure to organic or inorganic dust or drugs known to cause pulmonary fibrosis
  • have interstitial lung disease other than IPF
  • have pulmonary fibrosis associated with connective tissue disease
  • have other forms of idiopathic interstitial pneumonia, such as desquamative interstitial pneumonia, acute interstitial pneumonia, nonspecific interstitial pneumonia, or cryptogenic organizing pneumonia
  • have end-stage IPF (total lung capacity of less than 45% of predicted value)
  • are listed for lung transplantation at the time of study enrollment
  • have significant heart problems
  • are pregnant or lactating (if female)

Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FG-3019 Low Dose
Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0.
Drug: FG-3019
FG-3019 will be administered per dose and schedule specified in the arm description.
Other Names:
  • Recombinant human monoclonal antibody
Experimental: FG-3019 Medium Dose
Participants will receive a single IV infusion of FG-3019 medium dose on Day 0.
Drug: FG-3019
FG-3019 will be administered per dose and schedule specified in the arm description.
Other Names:
  • Recombinant human monoclonal antibody
Experimental: FG-3019 High Dose
Participants will receive a single IV infusion of FG-3019 high dose on Day 0.
Drug: FG-3019
FG-3019 will be administered per dose and schedule specified in the arm description.
Other Names:
  • Recombinant human monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline up to 12 months
Baseline up to 12 months
Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019
Time Frame: Through 30 hours postdose
Through 30 hours postdose
Number of Participants With Human Anti-human Antibody (HAHA)
Time Frame: Baseline up to 12 months
Baseline up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FibroGen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2003

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

December 18, 2003

First Submitted That Met QC Criteria

December 19, 2003

First Posted (Estimated)

December 22, 2003

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGCL-MC3019-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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