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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FG-3019
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic pulmonary fibrosis, IPF, Pulmonary fibrosis, Respiratory disease

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Jewish Medical and Research Center
  • University of Michigan Health Sciences
  • Southwestern Medical School
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

FG-3019 Low Dose

FG-3019 Medium Dose

FG-3019 High Dose

Arm Description

Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0.

Participants will receive a single IV infusion of FG-3019 medium dose on Day 0.

Participants will receive a single IV infusion of FG-3019 high dose on Day 0.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019
Number of Participants With Human Anti-human Antibody (HAHA)

Secondary Outcome Measures

Full Information

First Posted
December 18, 2003
Last Updated
July 11, 2023
Sponsor
FibroGen
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1. Study Identification

Unique Protocol Identification Number
NCT00074698
Brief Title
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
Official Title
A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2003 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
FibroGen

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic pulmonary fibrosis, IPF, Pulmonary fibrosis, Respiratory disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FG-3019 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0.
Arm Title
FG-3019 Medium Dose
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of FG-3019 medium dose on Day 0.
Arm Title
FG-3019 High Dose
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of FG-3019 high dose on Day 0.
Intervention Type
Drug
Intervention Name(s)
FG-3019
Other Intervention Name(s)
Recombinant human monoclonal antibody
Intervention Description
FG-3019 will be administered per dose and schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame
Baseline up to 12 months
Title
Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019
Time Frame
Through 30 hours postdose
Title
Number of Participants With Human Anti-human Antibody (HAHA)
Time Frame
Baseline up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Michigan Health Sciences
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Southwestern Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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

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