An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers.
The study will enroll approximately 50 eligible healthy male and female subjects between the ages of 18 to 55 inclusive. There will be 5 parallel dose cohorts (Cohorts 1-5) consisting of 10 subjects in each cohort. No subject will be a member of more than 1 cohort. Subjects will receive 3 administrations of study medication.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
PAREXEL, Early Phase Clinical Unit-Los Angeles
Glendale, California, United States
Cmax, Maximum observed serum concentration
Time frame: Date of enrollment to Day 57
Tmax, Time of maximum observed serum concentration
Time frame: Date of enrollment to Day 57
AUC, Area under the plasma concentration versus time curve
Time frame: Date of enrollment to Day 57
CL, Clearance of drug from the body
Time frame: Date of enrollment to Day 57
Vz, Volume of distribution
Time frame: Date of enrollment to Day 57
F, bioavailability of a SC dose relative to an IV dose
Time frame: Date of enrollment to Day 57
Number of participants with adverse events that are related to treatment
Time frame: Date of enrollment to Day 57
Number of participants with severe adverse events that are related to treatment
Time frame: Date of enrollment to Day 57
Number of participants with abnormal laboratory values related to treatment
Time frame: Date of enrollment to Day 57
Number of participants with abnormal ECGs related to treatment
Time frame: Date of enrollment to Day 57
Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57
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Time frame: Date of enrollment to Day 57
Percent of participants positive in the assay at at least one time point
Time frame: Date of enrollment to Day 57
Percent of participants with increasing titers of anti-drug antibody over time
Time frame: Date of enrollment to Day 57