Healthy Subjects and Atopic Dermatitis Subjects Clinical Trial
Official title:
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
The purpose of the study is to determine safety and tolerability of IL-31 mAB
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com Inclusion Criteria: - Part 1: Healthy subjects - Part 2: Adult subjects with: 1. 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 2. 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Local Institution | Manchester | Greater Manchester |
| United Kingdom | Local Institution | Manchester | |
| United Kingdom | Local Institution | Newcastle Upon Tyne | Tyne And Wear |
| United Kingdom | Local Institution | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose | No | |
| Secondary | The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time | 13 timepoints upto 16 weeks after single dose | No | |
| Secondary | 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 | No |