NCT02955459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

November 2, 2016

Last Update Submit

July 20, 2017

Conditions

Bacterial Infections

Keywords

Healthy volunteersPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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.

    Part 1: 8 days. Part 2: 17 days

Study Arms (2)

VNRX-5133

EXPERIMENTAL

IV infusion

Drug: VNRX-5133

Placebo

PLACEBO COMPARATOR

IV infusion

Drug: Placebo

Interventions

VNRX-5133DRUG
VNRX-5133
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lenexa, Kansas, United States

Location

Related Publications (1)

  • 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.

    PMID: 34370573DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

taniborbactam

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)