Healthy Subjects and Atopic Dermatitis Subjects
Conditions
Brief summary
The purpose of the study is to determine safety and tolerability of IL-31 mAB
Detailed description
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
Interventions
BIOLOGICALBMS-981164
BIOLOGICALPlacebo matching with BMS-981164
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 | Up to 16 weeks after single dose | The Immunogenicity of BMS-981164 will be assessed by this ADA assessments |
| 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 | — |
Countries
United Kingdom
Outcome results
None listed