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| ID | Type | Description | Link |
|---|---|---|---|
| 3243K1-1000 |
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See termination reason in detailed description.
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This is a "first in human" study to determine the safety and tolerability of the drug after single doses. Nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people. One third of the participants will be given an injection or infusion of placebo (sugar water). All participants will be healthy people.
First in human single dose study. Study terminated 12 October 2011. The ATR-107 Development team reached a recommendation to terminate further development of ATR-107 (PF-05230900). This was based on a number of factors, including development of anti-drug antibodies in approximately 70% of subjects in the First-in-Human study in healthy volunteers (B2281001). This recommendation is not based on adverse events observed in study B2281001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - SC injection | Placebo Comparator |
| |
| Drug dose level 1 - SC injection | Experimental |
| |
| Drug dose level 2 - SC injection | Experimental |
| |
| Drug dose level 3- SC injection | Experimental |
| |
| Drug dose level 4 - SC injection | Experimental |
| |
| Drug dose level 5 - SC injection | Experimental |
| |
| Drug dose level 6 - IV Infusion | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo SC Injection | Drug | Single injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent AEs and SAEs, AEs leading to withdrawal, immunogenicity, injection and infusion reactions, and clinically significant changes in laboratory tests, vital signs and ECGs if reported. | 20 months | |
| Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz | 19 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug dose level 7 - IV Infusion | Experimental |
|
| Drug dose level 8 - IV infusion | Experimental |
|
| Placebo - IV infusion | Placebo Comparator |
|
| Drug dose level 9 - IV infusion | Experimental |
|
| ATR-107 (PF-05230900) SC Injection |
| Drug |
Single intravenous infusion, 60 minute duration |
|
| ATR-107 (PF-05230900) SC Injection | Drug | Single subcutaneous injection |
|
| ATR-107 (PF-05230900) SC Injection | Drug | Single subcutaneous injection |
|
| ATR-107 (PF-05230900) SC Injection | Drug | Single subcutaneous injection |
|
| ATR-107 (PF-05230900) SC Injection | Drug | Single subcutaneous injection |
|
| ATR-107 (PF-05230900) IV Infusion | Drug | Single subcutaneous injection |
|
| ATR-107 (PF-05230900) IV Infusion | Drug | Single intravenous infusion, 60 minute duration |
|
| ATR-107 (PF-05230900) IV Infusion | Drug | Single intravenous infusion, 60 minute duration |
|
| Placebo IV Infusion | Drug | Single intravenous infusion, 60 minute duration |
|
| ATR-107 (PF-05230900) IV Infusion | Drug | Single intravenous infusion, 60 minute duration |
|
| Overland Park |
| Kansas |
| 66211 |
| United States |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000591157 | ATR-107 |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
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