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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMP-110 | Experimental | Escalating doses of AMP-110 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMP-110 | Biological | Dose levels 1 through 7: Single intravenous infusion on Day 0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo | Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56) | From start of study drug administration through Day 56 |
| Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials | Based on the occurrence of dose-limiting toxicities (through Day 14) | From start of study drug administration through Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate pharmacokinetic profile of a single dose of AMP-110 | Pharmacokinetics evaluated by area under the serum concentration versus time curve (AUC), peak serum concentration (Cmax), and clearance (Cl) of AMP-110 | From Day 0 pre-dose through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess pharmacokinetic and pharmacodynamic relationships | Determine if pharmacodynamics effects of AMP-110 on certain cytokine levels and T cell subsets are dependent on serum drug concentrations | From Day 0 pre-dose through Day 56 |
| Evaluate exploratory biomarkers |
Inclusion Criteria:
Must be able to provide written informed consent
Body mass index 18.5 to 35.0 kg/m2
Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
Global Functional Class I, II, or III according to ACR 1991 revised criteria
Stable use of >/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for >/= 4 weeks prior to Day 0, including:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Altoona Center for Clinical Research |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo |
| Other |
Dose levels 4 through 7: Single intravenous infusion on Day 0 |
|
Blood samples will be analyzed throughout the study to characterize the physiological effects of AMP-110 treatment and to determine markers that correlate with response to treatment |
| From start of study drug administration through Day 56 |
| Duncansville |
| Pennsylvania |
| 16635 |
| United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |