VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers | NCT04243863

Studies
VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

NCT04243863

Sponsor

Basilea Pharmaceutica

Status

Completed

Last Update Posted

Dec 3, 2025Actual

Enrollment

83Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

VNRX-7145
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
272201600029C-P00007-9999-2	U.S. NIH Grant/Contract		View source
18-0012	Other Identifier	DMID

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2020Actual

Primary Completion Date

Apr 5, 2021Actual

Completion Date

Apr 5, 2021Actual

First Submitted Date

Jan 14, 2020

First Submission Date that Met QC Criteria

Jan 24, 2020

First Posted Date

Jan 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 3, 2025Actual

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VNRX-7145	Experimental	Oral dosing	Drug: VNRX-7145
Placebo	Placebo Comparator	Oral dosing	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VNRX-7145	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Number of subjects with adverse events		Day 8
Part 2: Number of subjects with adverse events		Day 17

Secondary Outcomes

Measure	Description	Time Frame
Part 1: AUC0-tau		Days 1-3
Part 1: Cmax		Days 1-3
Part 1: tmax

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kamal Hamed, MD	Basilea Pharmaceutica International Ltd, Allschwil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Worldwide Clinical Trials Early Phase Services, LLC		San Antonio	Texas	78217	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40762486	Derived	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.