Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001865-34 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine safety and tolerability of IL-31 mAB
Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)
Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo | Experimental | Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
|
| Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo | Experimental | Part 1 Single dose of BMS-981164 0.01 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
|
| Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo | Experimental | Part 1 Single dose of BMS-981164 0.03 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
|
| Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo | Experimental | Part 1 Single dose of BMS-981164 0.06 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
|
| Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-981164 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests | Up to 16 weeks after single dose |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose | |
| The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Part 1: Healthy subjects
Part 2: Adult subjects with:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Manchester | Greater Manchester | M15 6SH | United Kingdom | ||
| Local Institution |
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
|
| Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo | Experimental | Part 1 Single dose of BMS-981164 0.3 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
|
| Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo | Experimental | Part 1 Single dose of BMS-981164 1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
|
| Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo | Experimental | Part 1 Single dose of BMS-981164 1 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
|
| Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo | Experimental | Part 1 Single dose of BMS-981164 3 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
|
| Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo | Experimental | Part 1 Single dose of BMS-981164 10.0 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
|
| Dose Escalation- BMS-981164 or Placebo (dose group 1) | Experimental | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose |
|
| Dose Escalation- BMS-981164 or Placebo (dose group 2) | Experimental | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
|
| Dose Escalation- BMS-981164 or Placebo (dose group 3) | Experimental | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
|
| Dose Escalation- BMS-981164 or Placebo (dose group 4) | Experimental | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and >1.0mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
|
|
| Placebo matching with BMS-981164 | Biological |
|
| 13 timepoints upto 16 weeks after single dose |
| The Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| The Area under the serum concentration-time curve from zero to time of the last quantifiable concentration [AUC(0-T)] of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| The Terminal serum half-life (T-HALF) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| The Apparent volume of distribution at steady state (Vss/F) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| The Volume of distribution at steady state (Vss) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| The Apparent total body clearance (CLT/F) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose |
| Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments | The Immunogenicity of BMS-981164 will be assessed by this ADA assessments | Up to 16 weeks after single dose |
| Newcastle upon Tyne |
| Tyne and Wear |
| NE1 4LP |
| United Kingdom |
| Local Institution | Manchester | M6 8HD | United Kingdom |
| Local Institution | Nottingham | NG11 6JS | United Kingdom |