Idiopathic Pulmonary FibrosisPhase 1NCT00074698
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing FG-3019 in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- FG-3019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Dec 2003to May 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and surgical lung biopsy or according to the American Thoracic Society criteria
Who cannot join
- 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
Show all 9Show fewer
- have significant heart problems
- are pregnant or lactating (if female)
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Health Sciences
Ann Arbor, Michigan, 48109
Southwestern Medical School
Dallas, Texas, 75390
National Jewish Medical and Research Center
Denver, Colorado, 80206
University of Washington Medical Center
Seattle, Washington, 98195
About this study
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
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- FG-3019
- Keywords
- Idiopathic pulmonary fibrosis, IPF, Pulmonary fibrosis, Respiratory disease
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-3019Drug
Also called Recombinant human monoclonal antibody
FG-3019 will be administered per dose and schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| FG-3019 Low Dose | Experimental | Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0. Receives: Drug: FG-3019 |
| FG-3019 Medium Dose | Experimental | Participants will receive a single IV infusion of FG-3019 medium dose on Day 0. Receives: Drug: FG-3019 |
| FG-3019 High Dose | Experimental | Participants will receive a single IV infusion of FG-3019 high dose on Day 0. Receives: Drug: FG-3019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to 12 months
Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019
Measured: Through 30 hours postdose
Number of Participants With Human Anti-human Antibody (HAHA)
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2003 (estimated)
- Study start8 Dec 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074698
- Sponsor's protocol ID
- FGCL-MC3019-002
- Status last verified
- Jul 2023
- First submitted
- 18 Dec 2003
- Last updated
- 12 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00074698
- Acronym / sponsor ID
- FGCL-MC3019-002
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic pulmonary fibrosis, IPF, Pulmonary fibrosis, Respiratory disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2003 (actual)
- Study completion
- May 2004
- First posted
- 22 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FG-3019 Low Dose | Experimental | Drug: FG-3019Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0. |
| FG-3019 Medium Dose | Experimental | Drug: FG-3019Participants will receive a single IV infusion of FG-3019 medium dose on Day 0. |
| FG-3019 High Dose | Experimental | Drug: FG-3019Participants will receive a single IV infusion of FG-3019 high dose on Day 0. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FG-3019Also: Recombinant human monoclonal antibodyFG-3019 will be administered per dose and schedule specified in the arm description. | Drug | FG-3019 High Dose, FG-3019 Low Dose, FG-3019 Medium Dose |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 12 months
Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019
Time frame: Through 30 hours postdose
Number of Participants With Human Anti-human Antibody (HAHA)
Time frame: Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FG-3019 in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.