This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein.
Placebo contains only excipients.
Shanghai General Hospita
Shanghai, Shanghai Municipality, China
Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities.
Time frame: From the time of informed consent through 92 days post dose.
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
Time frame: From Day 1 through 92 days post dose.
Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])
Time frame: From Day 1 through 92 days post dose.
Maximum Observed Serum Concentration (Cmax)
Time frame: From Day 1 through 92 days post dose.
Terminal Phase Elimination Half-life (t1/2)
Time frame: From Day 1 through 92 days post dose.
Elimination Rate Constant (Kel)
Time frame: From Day 1 through 92 days post dose.
Mean Residence Time (MRT)
Time frame: From Day 1 through 92 days post dose.
Apparent Serum Clearance (CL)
Time frame: From Day 1 through 92 days post dose.
Apparent Volume of Distribution (Vd)
Time frame: From Day 1 through 92 days post dose.
Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap)
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Time frame: From Day 1 through 92 days post dose.
Anti Drug Antibody (ADA) Assessments - Serum
ADA responses to XJ101
Time frame: From Day 1 through 92 days post dose.