This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in healthy subjects and in subjects with atopic disease.
The study will be divided into 2 parts. Part A will be an open-label, parallel group, BA study evaluating 4 once-weekly doses of IV XmAb7195 or SC XmAb7195 in healthy subjects. Each of 5 treatment groups will consist of 6 subjects. Part B will commence following the completion of Part A and will be a randomized, double-blind, placebo-controlled, MAD study evaluating 4 once weekly doses of SC XmAb7195 in healthy subjects and/or subjects with atopic disease. Each treatment group will consist of 8 subjects randomized 3:1 to XmAb7195:placebo Subjects in both parts of the study will be followed for at least 28 days after their last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
57
ICON Early Phase Services, LLC
San Antonio, Texas, United States
Bioavailability of SC XmAb7195 after 4 once-weekly doses as measured by the ratio of dose-normalized SC XmAb7195 area under the concentration-time curve (AUC) to dose-normalized IV XmAb7195 AUC.
Time frame: Date of randomization up to Day 50
Cmax, Maximum observed serum concentration
Time frame: Date of randomization up to Day 50
Time at which Cmax was observed [Tmax]
Time frame: Date of randomization up to Day 50
Area Under the Curve (AUC)
Time frame: Date of randomization up to Day 50
Terminal elimination half-life [t1/2]
Time frame: Date of randomization up to Day 50
Total body or systemic clearance [CL]
Time frame: Date of randomization up to Day 50
Apparent volume of distribution at steady state [Vss]
Time frame: Date of randomization up to Day 50
Immunogenicity of SC XmAb7195 and IV XmAb7195 as measured by incidence of development of anti-XmAb7195 antibody after 4 once-weekly doses
Time frame: Date of randomization up to Day 50
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