The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of NAV-240 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
40
Syneos Health
Miami, Florida, United States
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs are defined as events that started after the first dose of study treatment or events that presented prior to the first dose of study drug but increased in severity after the first dose based on preferred term, including clinically relevant abnormal laboratory findings. SAEs are defined as any event that either results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: From the dose of study drug on Day 1 up to Day 71
Maximum Serum Concentration (Cmax) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Time to Maximum Serum Concentration (Tmax) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Area Under the Serum Concentration-Time Curve From Time Zero to 336 hours post-dose (AUC0-336) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Area Under the Serum Concentration-Time Curve from Time Zero to the Concentration at a given Time Point (AUC0-t) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Serum Elimination Half-life (t1/2) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
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Terminal Elimination Rate Constant (λz) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Apparent Total Body Clearance (CL) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Apparent Volume of Distribution (Vz) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Trough Serum Concentration (Ctrough) of NAV-240
Time frame: From Day 1 prior to the first dose of study drug up to Day 71
Incidence of Presence of Antidrug Antibodies (ADAs)
The formation of ADAs against NAV-240 as assessed in blood samples. Proportion of participants with positive or negative results for ADAs.
Time frame: From the first dose of study drug up to Day 71
ADA Titers in Participants with Positive ADA
Time frame: From the first dose of study drug up to Day 71