Safety and Pharmacokinetics of VNRX-5133 in the Epithelial Lining Fluid of Healthy Adult Subjects

Venatorx Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: VNRX-5133 + cefepime

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT03870490

18-0001 (Other Identifier)

272201300019C-17-0-3 (U.S. NIH Grant/Contract)

VNRX-5133-106

Details and patient eligibility

About

This is a single-center, open-label study to assess safety and pharmacokinetics of VNRX-5133 and cefepime in the epithelial lining fluid in healthy adult male and female subjects.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Willing to participate in the trial, give written informed consent, and comply with the trial restrictions
Gender: male or female with a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at Screening and Day -1; females may be of childbearing potential or of nonchildbearing potential
Age: ≥18 years at Screening
Weight: ≥50 kg
Body mass index (BMI): ≥18 kg/m2 and <30 kg/m2
Normal blood pressure (BP), defined as a systolic value ≥90 mm Hg and ≤140 mm Hg and a diastolic value <90 mm Hg (Screening and Day -1)
All values for hematology and clinical chemistry tests of blood and urine are either within normal limits of laboratory reporting range (WNL) or defined as permitted exceptions
Ability and willingness to abstain from alcohol, from 48 hours (2 days) prior to admission to the Clinical Research Center (CRC) until discharge from the CRC
Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during this trial and for 90 days after the last dose of study drug
All over-the-counter (OTC) medications, health supplements, and herbal remedies (eg, St. John's Wort extract) must have been stopped at least 14 days prior to admission to the CRC
Suitable veins for cannulation/multiple venipunctures as assessed by the Investigator at Screening

Exclusion criteria

Employee of the Contract Research Organization (CRO), CRC, or the Sponsor
Female who is pregnant, lactating, or at risk of becoming pregnant during this trial or within 90 days after the last dose of study drug
Male with a female partner who is pregnant or lactating during this trial or planning to attempt to become pregnant during this trial or within 90 days after the last dose of study drug
Use of any investigational drug or device within 30 days prior to Screening (90 days for an injectable biological agent)
Presence of a congenital or acquired immunodeficiency syndrome
Any evidence or history of clinically significant medical abnormalities on PE or laboratory assessment
Clinically significant ECG abnormality
Sitting systolic BP >140 mm Hg or diastolic BP >90 mm Hg on a single measurement following at least 5 minutes of rest at Screening
History of drug allergy of a severity that required urgent medical treatment such as treatment with epinephrine in an Emergency Department
History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug or any component of VNRX-5133 for injection formulation
History of hypersensitivity to lidocaine, midazolam, fentanyl, or other topical anesthetics/opioids in similar classes to these agents
Use of prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study drug
History of donation of >450 mL of blood within 60 days prior to first dose of study drug or planned donation before 30 days has elapsed since final dose of study drug
Plasma or platelet donation within 7 days of first dose of study drug or planned donation during this trial
Current suspected drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria
Recent history of alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 standard drink=5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months before Screening
Use of tobacco- or nicotine-containing products from Screening through Check Out