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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
93
Local Institution
Manchester, Greater Manchester, United Kingdom
Local Institution
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Local Institution
Manchester, United Kingdom
Local Institution
Nottingham, United Kingdom
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
Time frame: Up to 16 weeks after single dose
The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 13 timepoints upto 16 weeks after single dose
The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time
Time frame: 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
Time frame: Up to 16 weeks after single dose