Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Venatorx Pharmaceuticals, Inc.
With
National Institutes of Health (NIH)
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
BMI: 18.5-40.0 kg/m2 with a minimum weight of 45 kg
Able and willing to abstain from alcohol from 48 h before admission until the follow-up visit
Suitable veins for cannulation/multiple venipunctures, as assessed by the Investigator at Screening
Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during the study and for 90 days after study drug administration.
Laboratory values meeting defined entry criteria
Subjects with normal renal function (Group 1) must also meet the following criteria:
Match to one or more subjects with renal impairment by gender, age, and weight
Subjects with renal impairment (Groups 2-5) must also meet the following criteria:
Stable, pre-existing renal impairment.
You may not be if
Employee of the study site, Contract Research Organization (CRO) or the IND Sponsor
Female who is pregnant, lactating, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
Male with a female partner who is pregnant or lactating during the study, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
Use of any investigational drug or device within 30 days before study drug administration (90 days for an injectable biological agent)
The subject has a congenital or acquired immunodeficiency syndrome
Screening or Day -1, clinically significant abnormal ECG values
Active malignancy; exceptions are permitted for carcinoma in situ of the prostate or the skin (basal cell or squamous cell) are permitted
History of drug allergy of a severity that required urgent medical treatment, such as treatment with epinephrine in an Emergency Department
Known immediate hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
History of donation of more than 450 mL of blood within 60 days before dosing in the site or planned donation before 30 days has elapsed since ingestion of study drug
Plasma or platelet donation within 7 days of dosing and throughout the study
Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year
Oral temperature \>38.5˚C or acute illness on Day -1
Previous participation in a study of VNRX-5133
Excluded concomitant medication
Clareo Health | VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment
