NCT04243863

Brief Summary

This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_1 healthy-volunteers

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

First Submitted

Initial submission to the registry

January 14, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

January 14, 2020

Last Update Submit

November 26, 2025

Conditions

Healthy Volunteers

Keywords

VNRX-7145SafetyPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Part 1: Number of subjects with adverse events

    Day 8

  • Part 2: Number of subjects with adverse events

    Day 17

Secondary Outcomes (8)

  • Part 1: AUC0-tau

    Days 1-3

  • Part 1: Cmax

    Days 1-3

  • Part 1: tmax

    Days 1-3

  • Part 1: CLr

    Days 1-3

  • Part 2: AUC0-tau

    Days 1-10

  • +3 more secondary outcomes

Study Arms (2)

VNRX-7145

EXPERIMENTAL

Oral dosing

Drug: VNRX-7145

Placebo

PLACEBO COMPARATOR

Oral dosing

Drug: Placebo

Interventions

PlaceboDRUG

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Placebo
VNRX-7145DRUG

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

VNRX-7145

Eligibility Criteria

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

You may qualify if:

  • Healthy adults 18-45 years
  • Males or non-pregnant, non-lactating females
  • Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m²
  • Normal blood pressure
  • Normal laboratory tests

You may not qualify if:

  • Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  • History of drug allergy
  • Abnormal ECG or history of clinically significant abnormal rhythm disorder
  • Positive alcohol, drug, or tobacco use/test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

  • de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5.

    PMID: 40762486DERIVED

Study Officials

  • Kamal Hamed, MD

    Basilea Pharmaceutica International Ltd, Allschwil

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 28, 2020

Study Start

January 20, 2020

Primary Completion

April 5, 2021

Study Completion

April 5, 2021

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations

US(1)