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This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose group |
|
| Cohort 2 | Experimental | Dose Group |
|
| Cohort 3 | Experimental | Dose Group |
|
| Cohort 4 | Experimental | Dose Group |
|
| Cohort 5 | Experimental | Dose Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC1008 | Biological | 0.3 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety, tolerability, and pharmacokinetics (PKs) of single intravenous (IV) infusions of GC1008 in patients with IPF | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate potential clinical outcomes and bioactivity of GC1008 | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver | Colorado | 80206 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33463535 | Derived | Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2):e143226. doi: 10.1172/JCI143226. |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C560928 | fresolimumab |
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| GC1008 | Biological | 1.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up. |
|
| GC1008 | Biological | 2.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up. |
|
| GC1008 | Biological | 4.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up. |
|
| GC1008 | Biological | 8.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up. |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Ann Arbor | Michigan | 48109 | United States |
| Minneapolis | Minnesota | United States |
| Rochester | Minnesota | 55905 | United States |
| Nashville | Tennessee | 37232 | United States |
| Seattle | Washington | 98195 | United States |
| Belgium | Belgium |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |