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VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VNRX-5133
Placebo
Sponsored by
Venatorx Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bacterial Infections focused on measuring Healthy volunteers, Pharmacokinetics

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults
  • Males or non-pregnant, non-lactating females
  • Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
  • Suitable veins for cannulation

Exclusion Criteria:

  • Employee of site or the sponsor
  • Any disease that poses an unacceptable risk to participants
  • Abnormal ECG
  • Abnormal labs
  • Abnormal vital signs
  • Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  • Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
  • Current smokers or history of smoking within 30 days

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VNRX-5133

Placebo

Arm Description

IV infusion

IV infusion

Outcomes

Primary Outcome Measures

Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2016
Last Updated
July 20, 2017
Sponsor
Venatorx Pharmaceuticals, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02955459
Brief Title
VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
Official Title
VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venatorx Pharmaceuticals, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Healthy volunteers, Pharmacokinetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VNRX-5133
Arm Type
Experimental
Arm Description
IV infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
VNRX-5133
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Time Frame
Part 1: 8 days. Part 2: 17 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults Males or non-pregnant, non-lactating females Body Mass Index (BMI) between 18.5 - 32.0, inclusive. Suitable veins for cannulation Exclusion Criteria: Employee of site or the sponsor Any disease that poses an unacceptable risk to participants Abnormal ECG Abnormal labs Abnormal vital signs Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1 Current smokers or history of smoking within 30 days
Facility Information:
City
Lenexa
State/Province
Kansas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34370573
Citation
Dowell JA, Dickerson D, Henkel T. Safety and Pharmacokinetics in Human Volunteers of Taniborbactam (VNRX-5133), a Novel Intravenous beta-Lactamase Inhibitor. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0105321. doi: 10.1128/AAC.01053-21. Epub 2021 Aug 9.
Results Reference
derived

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VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

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