A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
10mg, 20mg or 40 mg IV IS-001 drug administered during surgery
robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
Las Palmas Medical Center
El Paso, Texas, United States
Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events
Time frame: 14 days
Evaluation of pharmacokinetic parameter of IS-001: Cmax
Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration
Time frame: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: Tmax
Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration
Time frame: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: t1/2
Pharmacokinetics for IS-001 as measured by terminal elimination half-life
Time frame: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: AUC
Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve
Time frame: 6 hours
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