A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of the study is to determine safety and tolerability of IL-31 mAB

Detailed Description
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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

Official Title
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A Two-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects With Atopic Dermatitis

Conditions
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Healthy Subjects and Atopic Dermatitis Subjects

Intervention / Treatment
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* Biological: BMS-981164
* Biological: Placebo matching with BMS-981164


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Part 1: Healthy subjects Part 2: Adult subjects with: Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or greater) on a scale of 0 to 5 Pruritus severity of at least 7 of 10 on a visual analog scale Exclusion Criteria: Receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study drug administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 1)<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 2)<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 3)<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |
| Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 4)<br>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 | Biological: BMS-981164<br> <br> * Other names: IL-31 mAB;Biological: Placebo matching with BMS-981164<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |