IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics

Study Overview
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Brief Summary
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A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001

Detailed Description
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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

Official Title
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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

Conditions
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Hysterectomy, Surgery

Intervention / Treatment
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* Drug: IS-001
* Device: da Vinci® Si/Xi Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between the ages of 18 and 65. Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging. Subject is willing and able to provide informed consent. Subject is considered capable of complying with study procedures. Subject has no medical history of liver or kidney disease. Subject has no evidence of NYHA Class II-IV cardiac disease. Subject has recent (< 3 months) clinical hematology (CBC) values within the acceptable values reference range. Subject has recent (< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range. Exclusion Criteria: Subject is pregnant or nursing. Subject has a history of alcoholism. Subject has a history of drug abuse. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subject has known human immunodeficiency virus (HIV) infection. Subject has been diagnosed with or treated for cancer in the last 2 years. Subject has a total body weight < 32 kg. Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg. Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV IS-001 drug<br>IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System | Drug: IS-001<br>* 10mg, 20mg or 40 mg IV IS-001 drug administered during surgery<br>Device: da Vinci® Si/Xi Surgical System<br>* robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetic parameter of IS-001: Cmax | Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration | 6 hours | 
| Evaluation of pharmacokinetic parameter of IS-001: Tmax | Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration | 6 hours | 
| Evaluation of pharmacokinetic parameter of IS-001: t1/2 | Pharmacokinetics for IS-001 as measured by terminal elimination half-life | 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 | 6 hours |