This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
29
Single dose of AK119 is administered via intravenous infusion to healthy subjects
Single dose of placebo is administered via intravenous infusion to healthy subjects
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Incidence of treatment-emergent AEs
Time frame: From signing of informed consent till end of study (approximately 64 days postdose)
Maximum serum concentration (Cmax) of AK119
Time frame: From baseline till end of study (approximately 64 days postdose)
Area under the concentration-time curve (AUC) of serum concentration of AK119
Time frame: From baseline till end of study (approximately 64 days postdose)
Percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From baseline till end of study (approximately 64 days postdose)
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