VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Vo... | NCT04845321

Studies
VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

NCT04845321

Sponsor

Venatorx Pharmaceuticals, Inc.

Status

Terminated

Last Update Posted

Jun 10, 2025Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

VNRX-9945
Placebo for VNRX-9945

Countries

New Zealand

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

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Part 2 terminated, unrelated to safety.

Expanded Access Info

Start Date

Jun 23, 2021Actual

Primary Completion Date

Oct 31, 2021Actual

Completion Date

Oct 31, 2021Actual

First Submitted Date

Apr 10, 2021

First Submission Date that Met QC Criteria

Apr 10, 2021

First Posted Date

Apr 14, 2021Actual

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

Jun 4, 2025

Last Update Posted Date

Jun 10, 2025Actual

Name	Class
Novotech (Australia) Pty Limited	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

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-9945.

Detailed Description

In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VNRX-9945	Experimental	Oral dosing	Drug: VNRX-9945
Placebo	Placebo Comparator	Oral dosing	Drug: Placebo for VNRX-9945

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VNRX-9945	Drug	Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)	VNRX-9945

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Number of subjects with adverse events		Up to 8 days after last administration of study drug
Part 2: Number of subjects with adverse events		Up to 8 days after last administration of study drug

Secondary Outcomes

Measure	Description	Time Frame
Part 1: AUC0-tau		Days 1-6 (Days 1-12 for fasted/fed cohort)
Part 1: Cmax		Days 1-6 (Days 1-12 for fasted/fed cohort)
Part 1: tmax

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults 18-55 years
Males or non-pregnant, non-lactating females
Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight >50 kg (110 lbs)
Normal blood pressure
Normal lab tests

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Zealand Clinical Research		Auckland			New Zealand